Discover our expertise in medicinal cannabis
The challenge:
As Europe's medicinal cannabis industry evolves, authorities enforce strict pharmaceutical regulatory standards for medical cannabis.
Our solution:
With decades of experience in the pharmaceutical industry and in medical cannabis, we support the transition towards standardized cannabis medicine.
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Extensive network in the pharmaceutical industry
Our vast network encompasses manufacturers, analytical laboratories, pharmacies, CROs, and policymakers alike. We collaborate with all major players specializing in medical cannabis in the EU and overseas.
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Core expertise in pharmaceutical R&D
With a decades-long track record in the development and registration of pharmaceutical products and our early involvement in the medicinal cannabis field, we hold a unique vantage point to facilitate the transition to registered medical cannabis products.
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Access to advanced delivery systems
Our approach enables you to benefit from early access to advanced dosage forms for oral and pulmonary use that improve the delivery of cannabinoids to patients.
Case studies
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The client: We partnered with a medtech startup to develop a novel thermal inhalation device for precise dosing of cannabinoids.
The challenge: The device, which incorporates a unique ceramic heating element, is on track for registration as a Class IIb medicinal product, adhering to MDR guideline 2001/83/EG and MDCG 2021-24 guidance. As no such device has been registered yet, this marks a significant stride in medicinal inhalation technology.
The solution: Leveraging our pharmaceutical development expertise and professional network, our responsibilities encompass defining the development program, connecting with key clinical and regulatory opinion leaders, and managing the pharmaceutical development from sourcing and qualifying active substances to manufacturing clinical supplies and preparing IMPD documentation.
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The challenge: We initiated the development of soft capsules containing cannabis extracts standardized for CBD and THC with the goal of compliance with pharmaceutical standards and specifications.
The solution: Navigating the challenge of sourcing GMP grade extracts, as well as the stability of some compounds and the purity profile in the drug product, we successfully developed multiple stable formulations, which have since been marketed.