Although medical cannabis is becoming increasingly established in the pharmaceutical sector in Germany, manufacturers, distributors and wholesalers are still faced with new challenges from the various local regulatory authorities, depending on the location of the company’s place of business.
Individual German state authorities deviate, sometimes massively, from the general view that medical cannabis is classified as a drug and categorize medical cannabis as an active pharmaceutical ingredient for an extemporaneous product.
“Therefore, please seek advice in good time – as early as possible – and develop a strategy concept together with TentaConsult. We will be happy to assist you in its implementation, both in the regulatory and in the quality (management) area. The close and timely coordination with your local competent authority is as important to us as the pragmatic and forward-looking strategy of a safe and sustainable quality concept. We are experienced and flexible enough to consider the interests of start-ups as well as those of established companies.”, states Ralf Sibbing, Managing Director or TentaConsult Pharma & Med GmbH
Together with the laboratory of DSI-pharm / Quality Services International GmbH (a Tentamus Company), which is already holding a narcotics license according to article 3 of German Narcotics Act (BtMG), TentaConsult is ready to support you in cannabis analysis and thus completing its services to such an extent that you can obtain all external services from one source.
TentaConsult currently supports numerous companies with consulting and implementation regarding:
- GMP conformity, GACP requirements
- Analytics (including stability testing),
- Release analysis including market releases,
- Assumption of responsible roles (BtMV / GHV / QP)
- EU import,
- Storage / wholesale,
- GDP guidelines,
- Placing on the market in accordance with the BtMG
- Marketability testing of your product ideas.
Your contact partner:
Ralf G. Sibbing
Phone: +49 160 712 33 08