Successfully Manage Your 3rd Country Inspection to Access EU Markets
Benefit from our proven track record to successful GxP licensing
Our Cansulting
We help you comply with all the regulatory requirements for market access in the EU as a One-Stop-Shop. Our in-house Qualified Person has deep Cannabis expertise, will guide you through inspection procedures and assure your fastest track to market.
Our end to end services include:
1. EU-GMP & EU-GDP compliance
2. GACP compliance
3. 3rd country inspections
4. Strategy & Market demand analysis
5. Regulatory advice
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Beyond compliance to strategic advice
Leveraging our wide expertise in the Cannabis field, we aspire to help you move beyond compliance into excellence.
Our advisory service brings in best practices from across the world to help you make decisions that drive product quality and help you be successful as a business.
Friendliness, helpfulness and consultative competence form the basis for our sustainable cooperation to work with you on an equal footing.
EU-GxP compliance
Our services include:
- Gap analysis
- Preparation of GMP Manufacturing, Import & Export and Wholesale License applications
- Support the recruitment of a Qualified Person and Security Director
- Design your manufacturing facility using lean manufacturing strategies to meet applicable GMP regulations
- Commissioning, Qualification and Validation (CQV) of manufacturing facilities
- Pre-audit compliance supervision
- Development and preparation of product specifications
- Preparation of the Quality Management System (QMS)
- Execution of internal, external and supplier audits
- Trainings of employees
GACP compliance
Our services include:
- Site Property Procurement
- Business strategy and model preparation
- Cultivation, Import & Export and Wholesale License Applications
- Recruitment of Technical and Security Director
- Definition of cultivation technology across all cultivation stages
- Definition and optimization of your cultivation schedule to achieve highest yields per year
- Support on designing your cultivation facility
- Standard Operating Procedures and Work Instructions
Strategy & market analysis
Our services include:
- Market & competitor screenings
- Market access roadmap
- KPI monitoring
Regulatory advise
A broad knowledge about regulations and authorities is mandatory for successful and sustainable market entry. That is why we rely on our own regulatory experts within the company to gather experience and excellence inhouse accompanied by a strong advisory board and network.
Facilitator for 3rd country inspections
In order to export medicinal products to the European Union, manufacturing companies outside the EU are generally required to obtain EU GMP certification from a supervisory authority based in the European Union. This authority will usually verify the EU GMP compliance of the manufacturing company’s facilities and processes as part of a so-called third country inspection.
We have successfully advised international clients on their path to GMP compliance. This experience enables us to accompany official inspections with expertise and confidence.
We act as a point of contact for the competent authorities, provide support in designing efficient procedures and apply for the import licence required for a third country inspection in accordance with Section 72 of the German Medicines Act.
We are currently serving client projects in following countries:
Our expert, with over 30 years in phytopharmaceuticals, excels in quality management, covering all aspects from lab to company leadership in international firms.
Dr. Wolfgang Stock
Qualified Person
Qualified Person according § 14 AMG
GMP auditor
Specialist pharmacist for pharmaceutical technology
more than 35 years of experience in management positions in drug development and manufacturing
Explore our other market access services
Cannaflos has the necessary manufacturing license to act as a pharmaceutical entrepreneur in the EU, enabling us to release products and act as wholesalers.
We distribute a wide range of pharmaceuticals based on Cannabis.
Our catalog is available in our Health Care Professional Area.
Raoul van de Loo
Head of Sales
I am your first point of contact for medicinal cannabis products at Cannaflos and take care of the entire process from order to delivery. My responsibilities also extend to supply chain optimization and quality management to ensure that you always receive high-quality products.