EU-GMP Roadmap
We accompany you on your journey to EU-GMP
In order to export medicinal products to the European Union, manufacturing companies outside the EU are required to obtain EU GMP certification from a supervisory authority based in the European Union.
We offer a end-to-end service to support you in your journey to EU-GMP.
Furthermore, we act as a point of contact for the German competent authorities. The standards for GMP compliance in Germany are among the highest in the EU and therefore enjoy a high level of recognition in the market.
How we support you…
Gap Analysis
1 Month
EU-GMP Pre-Audit And Audit
Context specific
Pharmaceutical Import Permit
Context specific
Product Development
2 months
EU-GMP Inspection
Onsite facilitation of 3rd country inspection
Product registration
Ongoing
We have a successful trackrecord
We have successfully advised international customers on their path to GMP compliance. We facilitated the first successful EU-GMP license for a cannabis company in:
Case study – BG Labs, Colombia
BG LABS engaged Cannaflos to accompany them on the demanding road to EU GMP certification and product export to the European Union for release through Cannaflos as Pharmaceutical Entrepreneur on the German pharmaceutical market.
Following a successful EU GMP Audit by Cannaflos’ Qualified Person, Cannaflos supported BGLABS in its constructive and efficient process and quality management elaboration. In November 2023, on application by Cannaflos, the administrative third country inspection was performed successfully, making BG LABS the first Colombian pharmaceutical company for medicinal cannabis that has been inspected on-site and certified by a German competent authority for EU GMP compliance.
“BG LABS has had the continuous support of Cannaflos, with whom we built the synergy to achieve the EU – GMP certification. Their collaboration, support, knowledge and experience have been valuable assets that contributed to the development of BG LABS SAS. Cannaflos has become a partner for BG LABS SAS, as our collaboration includes commercial projects, which reflect the synergy and joint work towards growth, innovation and commitment with the medical community and patients. The shared strategic vision between BG LABS SAS and Cannaflos has been translated into the identification and development of commercial opportunities that take full advantage of our collective capabilities. These commercial projects not only strengthen our position in the marketplace, but also demonstrate the capacity of both companies to collaborate effectively in pursuit of shared goals.”
CLAUDIA PUENTES VARGAS
CEO – BG LABS S.A.S.
Have 30 years of experience guiding you through your 3rd country inspections.
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 services in Market Access
Include qualified EU-GMP services from our network of collaborators into your supply chain.
We enable EU-Import, Product
Release & Commercial Representation of your cannabinoid-based products in Germany