{"id":966,"date":"2026-08-25T12:06:19","date_gmt":"2026-08-25T10:06:19","guid":{"rendered":"https:\/\/staging.cannaconsult.eu\/?st-import=a9969e1cd98dfb0b331579c7cd809abb"},"modified":"2026-09-16T16:35:54","modified_gmt":"2026-09-16T14:35:54","slug":"services","status":"publish","type":"page","link":"https:\/\/cannaconsult.eu\/en\/services\/","title":{"rendered":"Services"},"content":{"rendered":"<div data-spectra-id=\"spectra-694e8fb1-6376-48fc-905f-42e7d6b2ab2d\"\tclass=\"has-image-background spectra-background-image spectra-is-root-container alignfull spectra-overlay-color wp-block-spectra-container is-vertical is-content-justification-center is-nowrap is-layout-flex wp-container-spectra-container-is-layout-769280d4 wp-block-spectra-container-is-layout-flex\" data-responsive-videos=\"{&quot;base&quot;:&quot;&quot;}\" data-orientation=\"vertical\"\t>\n\t\n<div data-spectra-id=\"spectra-150c274c-1d1f-4a9d-9f1a-7525176f27e4\" class=\"spectra-overlay-color wp-block-spectra-container is-nowrap is-layout-flex wp-container-spectra-container-is-layout-7b60ca05 wp-block-spectra-container-is-layout-flex\" data-orientation=\"horizontal\">\n\t\n<div data-spectra-id=\"spectra-13dbe1db-fe1d-47d9-8e24-0eb57757bf5c\" class=\"has-image-background spectra-background-image spectra-overlay-color wp-block-spectra-container is-layout-flex wp-container-spectra-container-is-layout-0f724195 wp-block-spectra-container-is-layout-flex\" data-responsive-videos=\"{&quot;base&quot;:&quot;&quot;}\" data-orientation=\"vertical\">\n\t\n\n<p class=\"has-ast-global-color-5-color has-text-color has-link-color wp-elements-1 wp-block-paragraph\" style=\"margin-top:5px;margin-bottom:15px;padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px\">In most cases, the main subject areas overlap in both theme and substance, making an intensive exchange of information between CannaConsult and our clients or partners essential - particularly during the initial phase. That is precisely why we offer the initial consultation FREE OF CHARGE.<\/p>\n\n\n\t<p data-spectra-id=\"spectra-001b574b-797f-4a0a-b923-717be58e6e1e\" class=\"has-text-color has-link-color spectra-text-color wp-elements-2 wp-block-spectra-content has-ast-global-color-5-color\" style=\"--spectra-text-color: var(--wp--preset--color--ast-global-color-5)\">\n\t\t<em>The descriptions below are not listed in chronological order or by priority. They are intended to provide guidance on the individual core areas.<\/em>\t<\/p>\n\n<\/div>\n\n\n<div data-spectra-id=\"spectra-mggew4ux-vdwsjv\" class=\"spectra-overlay-color wp-block-spectra-container is-layout-flex wp-container-spectra-container-is-layout-0f724195 wp-block-spectra-container-is-layout-flex\" data-orientation=\"vertical\">\n\t\n\t<h2 data-spectra-id=\"spectra-mggb5flt-gk01sl\" class=\"has-text-color has-link-color spectra-text-color wp-elements-3 wp-block-spectra-content has-ast-global-color-5-color\" style=\"--spectra-text-color: var(--wp--preset--color--ast-global-color-5)\">\n\t\tQuality. Compliance. Efficiency. Trust. Success.\t<\/h2>\n\n<\/div>\n\n<\/div>\n\n<\/div>\n\n\n<div data-spectra-id=\"spectra-mggf1mrc-r9308p\"\tclass=\"spectra-is-root-container alignfull spectra-overlay-color wp-block-spectra-container is-vertical is-content-justification-center is-nowrap is-layout-flex wp-container-spectra-container-is-layout-769280d4 wp-block-spectra-container-is-layout-flex\" data-orientation=\"vertical\"\t>\n\t\n\n<p class=\"portfolio-anker has-ast-global-color-0-background-color has-background wp-block-paragraph\" id=\"portfolio-uebersicht\">Table of Contents<\/p>\n\n\n<style>.kb-table-of-content-nav.kb-table-of-content-id966_c8ef67-a9 .kb-table-of-content-wrap{padding-top:var(--global-kb-spacing-sm, 1.5rem);padding-right:var(--global-kb-spacing-sm, 1.5rem);padding-bottom:var(--global-kb-spacing-sm, 1.5rem);padding-left:var(--global-kb-spacing-sm, 1.5rem);box-shadow:0px 0px 14px 0px rgba(0, 0, 0, 0.2);}.kb-table-of-content-nav.kb-table-of-content-id966_c8ef67-a9 .kb-table-of-contents-title-wrap{padding-top:0px;padding-right:0px;padding-bottom:0px;padding-left:0px;}.kb-table-of-content-nav.kb-table-of-content-id966_c8ef67-a9 .kb-table-of-contents-title{font-weight:regular;font-style:normal;}.kb-table-of-content-nav.kb-table-of-content-id966_c8ef67-a9 .kb-table-of-content-wrap .kb-table-of-content-list{font-weight:regular;font-style:normal;margin-top:var(--global-kb-spacing-sm, 1.5rem);margin-right:0px;margin-bottom:0px;margin-left:0px;}.kb-table-of-content-nav.kb-table-of-content-id966_c8ef67-a9 .kb-table-of-content-wrap .kb-table-of-content-list .kb-table-of-contents__entry:hover{color:var(--ast-global-color-0);}<\/style>\n\n<div data-spectra-id=\"spectra-mu3yxczr-9vmer8\" class=\"wp-block-spectra-separator spectra-separator-color\" style=\"--spectra-separator-color: var(--ast-global-color-0)\">\n\t<div class=\"spectra-separator-line\"><\/div>\n<\/div>\n\n\n<div data-spectra-id=\"spectra-c2046df7-e954-4d9d-b883-afd4f1e0b256\" class=\"spectra-overlay-color wp-block-spectra-container is-vertical is-content-justification-center is-nowrap is-layout-flex wp-container-spectra-container-is-layout-769280d4 wp-block-spectra-container-is-layout-flex\" data-orientation=\"vertical\">\n\t\n\n<h2 id=\"eugacp\" class=\"wp-block-heading portfolio-anker\">EU-GACP<\/h2>\n\n\n\n<h6 class=\"wp-block-heading\">EU-GACP Compliance for Controlled and Traceable Starting Materials<\/h6>\n\n\n\n<p class=\"wp-block-paragraph\">A robust medicinal-cannabis supply chain does not begin with GMP manufacturing, but at cultivation, harvesting, and the processing of the botanical starting material. We support companies in establishing, assessing, and continuously improving their cultivation and post-harvest processes in line with <strong>EU-GACP<\/strong> requirements.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Our consulting approach combines regulatory requirements with the operational realities of the business. Together with you, we analyse existing processes, responsibilities, facilities, hygiene concepts, and documentation systems. We examine the complete journey of the botanical material\u2014from seed or propagation material through cultivation, harvesting, and drying to packaging, storage, and handover to a GMP-processing facility.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A particular focus is placed on reducing microbiological, chemical, and physical contamination risks. This includes, for example, water and substrate management, pest-control and hygiene concepts, control of critical environmental conditions, harvesting hygiene, and the prevention of cross-contamination. \nEqually important is robust, traceable documentation that supports batch integrity, traceability, and the subsequent transfer into GMP-compliant processes.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Our services include, among others:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Conducting gap analyses against the relevant EU-GACP expectations.<\/li>\n\n\n\n<li>Development and optimization of SOPs, work instructions, and documentation templates.<\/li>\n\n\n\n<li>Establishment of risk-based hygiene concepts and contamination-control measures.<\/li>\n\n\n\n<li>Consulting on harvesting, drying, packaging, and storage processes.<\/li>\n\n\n\n<li>Assessment of traceability from starting material through to the released batch.<\/li>\n\n\n\n<li>Preparation for customer, certification, or regulatory-authority audits.<\/li>\n\n\n\n<li>Support in the structured transfer of suitable processes into the GMP environment.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Our goal is to establish a system that is not only convincing on paper. It should be clear, practical to implement, and auditable in day-to-day operations. In this way, we lay the foundation for consistent quality, robust supply chains, and sustainable growth for your business.<\/p>\n\n\n<div data-spectra-id=\"spectra-mu159uny-1nn5hd\" class=\"wp-block-button spectra-buttons wp-block-spectra-buttons\">\n\t\n<a data-spectra-id=\"spectra-mu159usq-ktt3pq\" href=\"\/en\/Contact\/\" target=\"_self\" aria-label=\"Start conversation\" class=\"wp-block-button__link wp-element-button wp-block-spectra-button\">\n<span class=\"spectra-button__link\">Start conversation<\/span><\/a>\n\n<\/div>\n\n\n\n<p class=\"has-ast-global-color-0-color has-text-color has-link-color wp-elements-4 wp-block-paragraph\"><a href=\"#portfolio-uebersicht\">back to Table of Contents<\/a><\/p>\n\n<\/div>\n\n\n<div data-spectra-id=\"spectra-4a7b93af-cfe6-42b5-9543-b8d4ed9fa9d5\" class=\"wp-block-spectra-separator spectra-separator-color\" style=\"--spectra-separator-color: var(--ast-global-color-0)\">\n\t<div class=\"spectra-separator-line\"><\/div>\n<\/div>\n\n\n<div data-spectra-id=\"spectra-a7e46abb-1960-4adf-b4f0-72847e96faa4\" class=\"spectra-overlay-color portfolio-anker wp-block-spectra-container is-vertical is-content-justification-center is-nowrap is-layout-flex wp-container-spectra-container-is-layout-769280d4 wp-block-spectra-container-is-layout-flex\" data-orientation=\"vertical\">\n\t\n\n<h2 id=\"eugmp-i--ii\" class=\"wp-block-heading portfolio-anker\">EU-GMP I + II<\/h2>\n\n\n\n<h6 class=\"wp-block-heading\">EU GMP Consulting for Manufacturing, Quality Assurance, and Regulatory Compliance<\/h6>\n\n\n\n<p class=\"wp-block-paragraph\">The manufacture of medicinal cannabis and cannabis-based medicinal products requires a GMP system that is both regulatory-compliant and operationally practical. We support companies in establishing, optimizing, and continuously developing quality management systems in accordance with <strong>EU-GMP Part I and Part II<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Whether you are planning a new manufacturing facility, further developing existing operations to achieve GMP compliance, or need to meet the requirements for a manufacturing authorisation, we help you translate regulatory expectations into clear processes, roles, and documentation. We work in a risk-based, structured manner and closely with your specialist departments.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Im Mittelpunkt stehen die Prozesse, die f\u00fcr Produktqualit\u00e4t und Patientensicherheit entscheidend sind. Dazu geh\u00f6ren unter anderem Personalqualifikation, Hygiene, R\u00e4umlichkeiten, Anlagen, Materialfl\u00fcsse, Dokumentation, Validierung, Abweichungsmanagement, Change Control und Chargenfreigabe. Bei Wirkstoffen und pflanzlichen Ausgangsmaterialien ber\u00fccksichtigen wir zus\u00e4tzlich die besonderen Anforderungen an Lieferanten, Spezifikationen, R\u00fcckverfolgbarkeit und Stabilit\u00e4tsdaten.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Whether you are planning a new manufacturing facility, further developing existing operations to achieve GMP compliance, or need to meet the requirements for a manufacturing authorisation, we help you translate regulatory expectations into clear processes, roles, and documentation. We work in a risk-based, structured manner and closely with your specialist departments.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>We support you for example with:<\/em><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>GMP gap analyses in accordance with EU GMP Part I and\/or Part II.<\/li>\n\n\n\n<li>Establishment and further development of GMP quality management systems.<\/li>\n\n\n\n<li>Drafting, reviewing, and harmonising SOPs, manufacturing instructions, and quality documents.<\/li>\n\n\n\n<li>Validations of manufacturing processes, cleaning, computerised-systems and product transport<\/li>\n\n\n\n<li>Qualification of equipment, premises, utilities, and suppliers.<\/li>\n\n\n\n<li>Preparation of Validation Master Plans and risk-based validation strategies.<\/li>\n\n\n\n<li>Development of stability protocols and evaluation of stability data.<\/li>\n\n\n\n<li>Preparation for GMP inspections, customer audits, and due diligence assessments.<\/li>\n\n\n\n<li>Support with applying for, maintaining, or extending licences and authorisations.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Our aim is to make regulatory complexity manageable for you. Rather than providing abstract, off-the-shelf templates, we deliver solutions tailored to your product, organisational structure, stage of development, and regulatory objectives.<\/p>\n\n\n<div data-spectra-id=\"spectra-312f3781-f353-492e-a366-6fbba70fdc06\" class=\"wp-block-button spectra-buttons wp-block-spectra-buttons\">\n\t\n<a data-spectra-id=\"spectra-a2f22898-267e-4fe4-9a07-e666ae9e834c\" href=\"\/en\/Contact\/\" target=\"_self\" aria-label=\"Start conversation\" class=\"wp-block-button__link wp-element-button wp-block-spectra-button\">\n<span class=\"spectra-button__link\">Start conversation<\/span><\/a>\n\n<\/div>\n\n\n\n<p class=\"has-ast-global-color-0-color has-text-color has-link-color wp-elements-5 wp-block-paragraph\"><a href=\"#portfolio-uebersicht\">back to Table of Contents<\/a><\/p>\n\n<\/div>\n\n\n<div data-spectra-id=\"spectra-a3217d3a-141c-4fe2-84f4-9bf0c2edc8e4\" class=\"wp-block-spectra-separator spectra-separator-color\" style=\"--spectra-separator-color: var(--ast-global-color-0)\">\n\t<div class=\"spectra-separator-line\"><\/div>\n<\/div>\n\n\n<div data-spectra-id=\"spectra-1ae2b3e9-b1c6-40bd-9fe6-e954ea07ab9d\" class=\"spectra-overlay-color wp-block-spectra-container is-vertical is-content-justification-center is-nowrap is-layout-flex wp-container-spectra-container-is-layout-769280d4 wp-block-spectra-container-is-layout-flex\" data-orientation=\"vertical\">\n\t\n\n<h2 id=\"eugdp\" class=\"wp-block-heading portfolio-anker\">EU-GDP<\/h2>\n\n\n\n<h6 class=\"wp-block-heading\">Safe Supply Chains and EU-GDP-compliant Distribution<\/h6>\n\n\n\n<p class=\"wp-block-paragraph\">The quality of a medicinal product must not be compromised on its journey from the manufacturer to the customer. Particularly for medicinal cannabis, controlled medicinal products, and temperature-sensitive products, secure, documented, and quality-assured supply chains are of central importance. We support you in establishing and further developing a system in line with the principles of <strong>EU-GDP<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Our consulting services are aimed at manufacturers, wholesalers, importers, logistics providers, and companies with international supply chains. Together with you, we develop processes that reliably integrate product quality, continuity of supply, traceability, and regulatory compliance.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">We do not look solely at individual shipments, we assess your entire distribution structure: supplier qualification, goods receipt, storage, temperature monitoring, order picking, transport, customer approval, complaints, recalls, and deviation management. We also systematically evaluate the interfaces with external warehousing and transport providers, as well as international partners.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">An effective GDP system creates transparency. It ensures that every product flow remains traceable, storage and transport conditions are maintained, and quality-relevant events are identified early and addressed effectively. This reduces operational risks while strengthening the confidence of customers, business partners, and regulatory authorities.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>Our Services include, among others:<\/em><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>GDP gap analyses and audit preparation.<\/li>\n\n\n\n<li>Establishment and optimisation of GDP Quality Management Systems and digitalisation.<\/li>\n\n\n\n<li>Development of SOPs for wholesale relevant processes such as storage, dispatch, recalls, complaints, deviations and CAPAs, etc...<\/li>\n\n\n\n<li>Qualification and oversight of logistics, warehousing, and transport service providers.<\/li>\n\n\n\n<li>Risk assessment of supply chains and transport routes.<\/li>\n\n\n\n<li>Consulting on temperature monitoring, temperature mapping, and data management.<\/li>\n\n\n\n<li>Development of contingency and escalation procedures for deviations or supply disruptions.<\/li>\n\n\n\n<li>Support with wholesale distribution authorisations, including their maintenance and extension.<\/li>\n\n\n\n<li>Planning and conducting supplier and transport audits.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">We help you establish a compliant EU-GDP system that works effectively in day-to-day operations while also standing up to audits and regulatory inspections. This ensures that distribution does not become a weak point, but rather a controlled and reliable part of your value chain.<\/p>\n\n\n<div data-spectra-id=\"spectra-4950b223-748f-4fc3-95c9-e736b8936947\" class=\"wp-block-button spectra-buttons wp-block-spectra-buttons\">\n\t\n<a data-spectra-id=\"spectra-5393fe3a-1dcf-4c06-ac34-44b1187815c7\" href=\"\/en\/Contact\/\" target=\"_self\" aria-label=\"Start conversation\" class=\"wp-block-button__link wp-element-button wp-block-spectra-button\">\n<span class=\"spectra-button__link\">Start conversation<\/span><\/a>\n\n<\/div>\n\n\n\n<p class=\"has-ast-global-color-0-color has-text-color has-link-color wp-elements-6 wp-block-paragraph\"><a href=\"#portfolio-uebersicht\">back to Table of Contents<\/a><\/p>\n\n<\/div>\n\n\n<div data-spectra-id=\"spectra-8bd85d9a-bb66-4ce0-a2e0-527af77a4c3d\" class=\"wp-block-spectra-separator spectra-separator-color\" style=\"--spectra-separator-color: var(--ast-global-color-0)\">\n\t<div class=\"spectra-separator-line\"><\/div>\n<\/div>\n\n\n<div data-spectra-id=\"spectra-b9e5f4fa-653d-456a-bff9-b792e1e06973\" class=\"spectra-overlay-color wp-block-spectra-container is-vertical is-content-justification-center is-nowrap is-layout-flex wp-container-spectra-container-is-layout-769280d4 wp-block-spectra-container-is-layout-flex\" data-orientation=\"vertical\">\n\t\n\n<h2 id=\"quality-control\" class=\"wp-block-heading portfolio-anker\">Quality Control<\/h2>\n\n\n\n<h6 class=\"wp-block-heading\">Quality Control with Scientific and Regulatory Assurance<\/h6>\n\n\n\n<p class=\"wp-block-paragraph\">Effective quality control is essential to ensure that medicinal cannabis and cannabis-based products reach the market with consistent quality, safety, and compliance with specifications. We advise you on the development, assessment, and optimisation of QC strategies, testing methods, and release processes.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The specific characteristics of herbal medicinal products and cannabis flowers require a thorough understanding of the interplay between raw-material variability, analytical methodology, regulatory requirements, and risk-based quality assessment. We support you in clearly defining the relevant quality attributes of your products and translating them into a robust testing strategy.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The focus encompasses chemical-analytical, microbiological, and physical testing. This may include, for example, cannabinoid content determination, terpene-profile analysis, moisture determination, water activity, microbiological testing, and testing for pesticides, heavy metals, mycotoxins, or other contaminants. The tests that are necessary and appropriate will always depend on the product type, manufacturing process, supply chain, target market, and regulatory strategy.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">We help you justify analytical decisions in a traceable manner, establish appropriate specifications, and place batch release on a robust data foundation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>Our Services include, among others:<\/em><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Development and review of quality control strategies.<\/li>\n\n\n\n<li>Consulting on appropriate specifications for starting materials, intermediate products, and finished products.<\/li>\n\n\n\n<li>Assessment of analytical methods and testing plans.<\/li>\n\n\n\n<li>Support with method validation, method verification, and method transfer.<\/li>\n\n\n\n<li>Consulting on the selection and qualification of external contract laboratories.<\/li>\n\n\n\n<li>Support with out-of-specification (OOS) results, atypical trends, and laboratory deviations.<\/li>\n\n\n\n<li>Development of investigation strategies for root cause analyses and CAPA measures.<\/li>\n\n\n\n<li>Consulting on relevant monographs, pharmacopoeias, and regulatory quality requirements.<\/li>\n\n\n\n<li>Support with batch documentation, analytical assessment, and batch release processes.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Our consulting combines scientific rigour with a clear focus on operational feasibility. The result is QC processes that effectively control relevant risks, manage costs and effort in a transparent manner, and provide a reliable basis for product release.<\/p>\n\n\n<div data-spectra-id=\"spectra-637989ec-13f5-4e2b-a780-f03d6bcf8632\" class=\"wp-block-button spectra-buttons wp-block-spectra-buttons\">\n\t\n<a data-spectra-id=\"spectra-64dd3e9d-d72a-480e-9940-23463c760255\" href=\"\/en\/Contact\/\" target=\"_self\" aria-label=\"Start conversation\" class=\"wp-block-button__link wp-element-button wp-block-spectra-button\">\n<span class=\"spectra-button__link\">Start conversation<\/span><\/a>\n\n<\/div>\n\n\n\n<p class=\"has-ast-global-color-0-color has-text-color has-link-color wp-elements-7 wp-block-paragraph\"><a href=\"#portfolio-uebersicht\">back to Table of Contents<\/a><\/p>\n\n<\/div>\n\n\n<div data-spectra-id=\"spectra-2f04aad7-d0ab-46ad-b698-8dfdfc027173\" class=\"wp-block-spectra-separator spectra-separator-color\" style=\"--spectra-separator-color: var(--ast-global-color-0)\">\n\t<div class=\"spectra-separator-line\"><\/div>\n<\/div>\n\n\n<div data-spectra-id=\"spectra-de8769ea-7708-4588-8950-750abbf5e1fc\" class=\"spectra-overlay-color wp-block-spectra-container is-vertical is-content-justification-center is-nowrap is-layout-flex wp-container-spectra-container-is-layout-769280d4 wp-block-spectra-container-is-layout-flex\" data-orientation=\"vertical\">\n\t\n\n<h2 id=\"qualitaetsmanagement\" class=\"wp-block-heading portfolio-anker\">Quality Management<\/h2>\n\n\n\n<h6 class=\"wp-block-heading\">Quality Management That Works in Practice<\/h6>\n\n\n\n<p class=\"wp-block-paragraph\">A quality management system is more than a collection of SOPs and forms. It provides the foundation for clear responsibilities, controlled processes, early identification of risks, and decisions that are documented in a traceable manner. We support you in establishing, optimising, and practically implementing an effective quality management system.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Our approach is guided by GxP requirements, the expectations of regulatory authorities and customers, and the actual operations of your business. We avoid unnecessary complexity. Together with you, we establish a quality framework that is robust enough to withstand audits and inspections, while also being accepted and put into practice by your employees on a daily basis.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">We begin with an initial assessment: Which processes are already in place? Where are there regulatory or organisational gaps? Which risks are particularly relevant? Based on this, we develop a prioritised action plan and support you in its implementation.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">We pay particular attention to the systems that enable continuous improvement in a regulated environment: deviation management, CAPA, change control, risk management, self-inspections, oversight of outsourced activities, supplier and customer management, and management reviews. These elements ensure that quality issues are not merely documented, but thoroughly understood and sustainably resolved.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>We support you, among other things, with:<\/em><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Establishing, restructuring, and further developing (e.g. digitalisation) of quality management systems.<\/li>\n\n\n\n<li>Development of quality manuals, SOP frameworks, and document control systems.<\/li>\n\n\n\n<li>Definitions of clear responsibilities, role profiles, and approval workflow processes.<\/li>\n\n\n\n<li>Implementation or improvement of deviation management, CAPA, and change control systems.<\/li>\n\n\n\n<li>Establishment or improvement of a Quality Risk Management System.<\/li>\n\n\n\n<li>Planning and execution of Self-Inspections.<\/li>\n\n\n\n<li>Preparation, facilitation, and documentation of Management Reviews.<\/li>\n\n\n\n<li>Schulung von Mitarbeitenden zu GxP, SOPs, Datenintegrit\u00e4t und Qualit\u00e4tskultur<\/li>\n\n\n\n<li>Support with the digitalisation and simplification of quality management processes.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">We see quality management as a leadership and governance tool. A well-designed system not only strengthens regulatory compliance, but also improves transparency, process stability, and collaboration across the organisation.<\/p>\n\n\n<div data-spectra-id=\"spectra-bf0e0dd6-b7c8-490e-ae8b-e2798a4ae1e3\" class=\"wp-block-button spectra-buttons wp-block-spectra-buttons\">\n\t\n<a data-spectra-id=\"spectra-c9da2e00-15fb-4869-b9e0-33fb03302cf0\" href=\"\/en\/Contact\/\" target=\"_self\" aria-label=\"Start conversation\" class=\"wp-block-button__link wp-element-button wp-block-spectra-button\">\n<span class=\"spectra-button__link\">Start conversation<\/span><\/a>\n\n<\/div>\n\n\n\n<p class=\"has-ast-global-color-0-color has-text-color has-link-color wp-elements-8 wp-block-paragraph\"><a href=\"#portfolio-uebersicht\">back to Table of Contents<\/a><\/p>\n\n<\/div>\n\n\n<div data-spectra-id=\"spectra-6b6f955b-6df4-4e3f-8871-a110a05d0600\" class=\"wp-block-spectra-separator spectra-separator-color\" style=\"--spectra-separator-color: var(--ast-global-color-0)\">\n\t<div class=\"spectra-separator-line\"><\/div>\n<\/div>\n\n\n<div data-spectra-id=\"spectra-32412136-c04b-4fef-9b68-5492c9255693\" class=\"spectra-overlay-color wp-block-spectra-container is-vertical is-content-justification-center is-nowrap is-layout-flex wp-container-spectra-container-is-layout-769280d4 wp-block-spectra-container-is-layout-flex\" data-orientation=\"vertical\">\n\t\n\n<h2 id=\"rechtliche-rahmen\" class=\"wp-block-heading portfolio-anker\">Regulatory Framework<\/h2>\n\n\n\n<h6 class=\"wp-block-heading\">Regulatory guidance for medicinal cannabis and pharmaceutical products<\/h6>\n\n\n\n<p class=\"wp-block-paragraph\">The legal framework for medicinal cannabis is complex and continues to evolve. Companies must comply not only with national requirements, but often also with European standards, international control obligations, and country-specific regulations throughout the supply chain. We help you understand these requirements at an early stage and translate them into a realistic corporate and product strategy.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Our consulting services are aimed at companies active in cultivation, processing, importation, wholesale, distribution, research, or development, as well as those planning to enter the market. We support you in structuring and assessing regulatory issues and in incorporating the necessary licences, permits, registrations, and quality requirements into your planning.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In doing so, we consider not only the formal legal framework, but also its practical implications: Which activities are covered by your current licence? Which regulatory requirements must be fulfilled before a business model can be launched? What requirements apply to suppliers, products, documentation, import and export processes, or product registrations?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>Our Services include, among others:<\/em><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Regulatory assessment of planned business models and activities.<\/li>\n\n\n\n<li>Analysis of German, European, and international regulatory requirements.<\/li>\n\n\n\n<li>Support with planning licensing, permit, and registration processes.<\/li>\n\n\n\n<li>Advice on manufacturing and wholesale distribution authorisations, as well as other required permits.<\/li>\n\n\n\n<li>Support with product registrations and medicinal products requiring marketing authorisation.<\/li>\n\n\n\n<li>Assessment of regulatory requirements for supply chains, imports, and exports.<\/li>\n\n\n\n<li>Support with the preparation and compilation of regulatory documentation.<\/li>\n\n\n\n<li>Support with communication and preparation for interactions with regulatory authorities.<\/li>\n\n\n\n<li>Ongoing monitoring of relevant regulatory developments affecting your business area.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">We create clarity before significant investments or operational decisions are made. This enables you to address regulatory risks at an early stage, avoid project delays, and establish a sound basis for your further planning.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>Note: Our consulting services do not replace individual legal advice provided by qualified legal counsel. Where legally binding matters arise, we work with specialised legal partners as required.<\/em><\/p>\n\n\n<div data-spectra-id=\"spectra-8a97eaf4-2fbc-42ef-8013-30b58a14f18f\" class=\"wp-block-button spectra-buttons wp-block-spectra-buttons\">\n\t\n<a data-spectra-id=\"spectra-c643d346-1242-43c8-9f91-469fc8456f98\" href=\"\/en\/Contact\/\" target=\"_self\" aria-label=\"Start conversation\" class=\"wp-block-button__link wp-element-button wp-block-spectra-button\">\n<span class=\"spectra-button__link\">Start conversation<\/span><\/a>\n\n<\/div>\n\n\n\n<p class=\"has-ast-global-color-0-color has-text-color has-link-color wp-elements-9 wp-block-paragraph\"><a href=\"#portfolio-uebersicht\">back to Table of Contents<\/a><\/p>\n\n<\/div>\n\n\n<div data-spectra-id=\"spectra-c68f78e5-d0e9-44d7-b100-9cf093defaf1\" class=\"wp-block-spectra-separator spectra-separator-color\" style=\"--spectra-separator-color: var(--ast-global-color-0)\">\n\t<div class=\"spectra-separator-line\"><\/div>\n<\/div>\n\n\n<div data-spectra-id=\"spectra-715a1836-9248-437d-9daf-9a33075ccb99\" class=\"spectra-overlay-color wp-block-spectra-container is-vertical is-content-justification-center is-nowrap is-layout-flex wp-container-spectra-container-is-layout-769280d4 wp-block-spectra-container-is-layout-flex\" data-orientation=\"vertical\">\n\t\n\n<h2 id=\"auftragsaudits\" class=\"wp-block-heading portfolio-anker\">Audits on Demand<\/h2>\n\n\n\n<h6 class=\"wp-block-heading\">Independent audits for reliable partners and resilient supply chains<\/h6>\n\n\n\n<p class=\"wp-block-paragraph\">Quality is not created solely within your own organisation. It depends significantly on whether suppliers, contract manufacturers, laboratories, logistics providers, and other outsourced service providers reliably meet the agreed quality and compliance requirements. We conduct independent contract audits in accordance with EU GxP requirements and support you with the qualification and requalification of your business partners.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Our audits are practical, risk-based, and tailored to the supplier\u2019s actual intended use. Not every business partner requires the same level of audit scrutiny. We therefore begin with a structured risk assessment: Which materials, services, or processes are being sourced? What impact do they have on product quality, patient safety, compliance, and security of supply? Which regulatory requirements apply?<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Based on this assessment, we plan and conduct on-site, remote, or document-based audits. We do not merely verify whether documents exist; we assess whether the systems described are effectively implemented in practice. Our reviews may cover quality management, personnel qualifications, premises, hygiene, documentation, deviation management, validation, supplier oversight, data integrity, and traceability.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Our experience in medicinal cannabis, active substances, and medicinal products enables us to identify, assess, and communicate industry-specific risks in a targeted and understandable manner.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>We support you with:<\/em><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Initial audits for the qualification of new suppliers and service providers.<\/li>\n\n\n\n<li>Requalification audits of existing business partners.<\/li>\n\n\n\n<li>GMP, GDP, GACP, and risk-based GxP audits.<\/li>\n\n\n\n<li>Audits of cultivation facilities, processors, laboratories, wholesalers, and logistics service providers.<\/li>\n\n\n\n<li>Planning and conducting remote audits.<\/li>\n\n\n\n<li>Audit reports with clear findings, risk classifications, and recommendations for corrective actions.<\/li>\n\n\n\n<li>Assessment and follow-up of corrective and preventive actions (CAPAs).<\/li>\n\n\n\n<li>Support with quality agreements and technical agreements.<\/li>\n\n\n\n<li>Support during customer audits or regulatory inspections.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">You receive an independent, clear, and decision-oriented assessment from us. Our aim is not to generate as many observations as possible, but to make risks transparent and identify practical paths for improvement. This enables you to base supplier decisions on a sound and reliable foundation.<\/p>\n\n\n<div data-spectra-id=\"spectra-b2008e6b-93b1-4fb7-9c04-bc2cf59da0e9\" class=\"wp-block-button spectra-buttons wp-block-spectra-buttons\">\n\t\n<a data-spectra-id=\"spectra-d1348443-11d5-4936-8452-faf54f151923\" href=\"\/en\/Contact\/\" target=\"_self\" aria-label=\"Start conversation\" class=\"wp-block-button__link wp-element-button wp-block-spectra-button\">\n<span class=\"spectra-button__link\">Start conversation<\/span><\/a>\n\n<\/div>\n\n<\/div>\n\n\n\n<p class=\"has-ast-global-color-0-color has-text-color has-link-color wp-elements-10 wp-block-paragraph\"><a href=\"#portfolio-uebersicht\">back to Table of Contents<\/a><\/p>\n\n\n<div data-spectra-id=\"spectra-22ed1665-a851-4d63-bff8-dc7f75f9049c\" class=\"wp-block-spectra-separator spectra-separator-color\" style=\"--spectra-separator-color: var(--ast-global-color-0)\">\n\t<div class=\"spectra-separator-line\"><\/div>\n<\/div>\n\n\n<div data-spectra-id=\"spectra-ff87e147-d08b-425f-bea4-d644a5191ac7\" class=\"spectra-overlay-color wp-block-spectra-container is-vertical is-content-justification-center is-nowrap is-layout-flex wp-container-spectra-container-is-layout-769280d4 wp-block-spectra-container-is-layout-flex\" data-orientation=\"vertical\">\n\t\n\n<h2 class=\"wp-block-heading has-text-align-left portfolio-anker\" id=\"business-und-investmentstrategien\">Investment Strategies<\/h2>\n\n\n\n<h6 class=\"wp-block-heading\">Regulatory-driven strategies for sustainable growth<\/h6>\n\n\n\n<p class=\"wp-block-paragraph\">Successful projects in the medicinal cannabis sector require more than a compelling product or a strong market idea. They need a strategy that integrates regulatory feasibility, quality, supply capability, capital requirements, and market opportunities from the outset. We support companies, entrepreneurs, and investors in developing robust business and investment strategies across the entire value chain.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Our perspective combines operational industry expertise with a critical assessment of opportunities and risks. We analyse not only the market, but above all whether a business model is viable under real-world regulatory, technical, and economic conditions.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Depending on the project, this may include assessing cultivation capacities, production sites, GMP upgrades, import and wholesale models, product portfolios, distribution structures, laboratory services, or strategic investments. We help you challenge key assumptions, identify operational risks, and base your decisions on transparent, well-substantiated facts.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A key focus of our work is the analysis of vertically integrated value chains. We assess which activities can sensibly be managed in-house and where specialised external partners may offer economic or regulatory advantages. Not every form of integration automatically creates value \u2014 what matters is control, quality, capital commitment, speed, and the ability to execute reliably.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong><em>Our consulting services include:<\/em><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Development and assessment of business models in the medicinal cannabis and pharmaceutical sectors.<\/li>\n\n\n\n<li>Strategic analysis of existing or planned supply and value chains.<\/li>\n\n\n\n<li>Assessment of opportunities, risks, and regulatory barriers to market entry.<\/li>\n\n\n\n<li>Support with market and competitive analyses.<\/li>\n\n\n\n<li>Due diligence support for investments, acquisitions, and investment decisions.<\/li>\n\n\n\n<li>Assessment of target companies\u2019 regulatory maturity and quality-related risks.<\/li>\n\n\n\n<li>Analysis of manufacturing, quality, supplier, and licensing risks.<\/li>\n\n\n\n<li>Support in identifying partners and suppliers, and in structuring collaborations.<\/li>\n\n\n\n<li>Development of prioritised roadmaps for company building, scaling, and market entry.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">We help you assess opportunities realistically and underpin investment decisions with deep sector expertise. This gives you more than a market overview: it provides a robust basis for decision-making that consistently takes regulatory requirements, quality risks, and operational execution into account.<\/p>\n\n\n<div data-spectra-id=\"spectra-c923c0db-7f6a-414c-b985-61aaecfc9b17\" class=\"wp-block-button spectra-buttons wp-block-spectra-buttons\">\n\t\n<a data-spectra-id=\"spectra-1500da83-eb38-4487-b90b-94d39d695f53\" href=\"\/en\/Contact\/\" target=\"_self\" aria-label=\"Start conversation\" class=\"wp-block-button__link wp-element-button wp-block-spectra-button\">\n<span class=\"spectra-button__link\">Start conversation<\/span><\/a>\n\n<\/div>\n\n\n\n<p class=\"has-ast-global-color-0-color has-text-color has-link-color wp-elements-11 wp-block-paragraph\"><a href=\"#portfolio-uebersicht\">back to Table of Contents<\/a><\/p>\n\n<\/div>\n\n\n<div data-spectra-id=\"spectra-4e8a0025-6e65-47ac-8233-0c76d076940e\" class=\"wp-block-spectra-separator spectra-separator-color\" style=\"--spectra-separator-color: var(--ast-global-color-0)\">\n\t<div class=\"spectra-separator-line\"><\/div>\n<\/div>\n\n<\/div>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"unboxed","site-sidebar-style":"unboxed","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"disabled","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"enabled","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center 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