Interdisciplinary Team of Experts and Network.
At CannaConsult, you gain access to expert knowledge spanning every area of the regulated medical-cannabis industry - and beyond. Our deep commitment to science and research, from clinical trials to product development, including formulations and finished pharmaceutical products, as well as innovative methods of administration, provides a highly valuable knowledge advantage that is essential for strategic business planning.
We do not rely on “self-proclaimed experts.” Every contributor brings several years of professional experience and demonstrable specialist expertise, which CannaConsult brings together for the benefit of our clients and partners. In addition to our subject-matter experts, our network includes established medical-cannabis companies whose active operational capabilities can be leveraged directly in partnerships.
Our Expertise and Specialist Competences
01.
EU-GACP
Consulting on suitable genetics. Compliance with EU-GACP, with a focus on process-optimisation to reduce contamination risks and on enhanced documentation requirements in preparation for transition to EU-GMP.
02.
EU-GMP I+II
Compliance with EU GMP Part I and/or Part II, with a focus on process validation, pharmaceutical quality management, and stability data. Support for maintaining, obtaining, or expanding the required licences and regulatory authorisations.
03.
EU-GDP
Compliance with EU GDP, focusing on quality management, supply-chain qualification, and ongoing monitoring. Support for maintaining, obtaining, or expanding the required licences and regulatory authorisations.
04.
Quality Control
Full analytical testing, analytical-method validation, root-cause investigations, and risk assessments for deviations; application of relevant monographs and pharmacopoeias (DAB and Ph. Eur.) and batch-release support.
05.
Quality Management
Pharmaceutical quality management systems (incl. digitalisation), SOP frameworks, personnel training, deviation and CAPA management, change control, quality-risk management, self-inspections, and management reviews.
06.
Regulatory Framework
German laws and ordinances, national and international regulations, regulatory authority requirements for certificates, licences, and permits; product registrations; and medicinal products subject to marketing authorisation.
07.
Audits on Demand
Audits for the initial- and re-qualification of suppliers, outsourced activities and customers in accordance with EU-GxP requirements - drawing on worldwide experience with medical cannabis as an API or medicinal product.
08.
Investment Strategies
Vertical integration through equity investments and strategic connectivity across existing or planned supply and value chains. Assessment of new product launches, including their commercial, regulatory and operational opportunities and risks.