CCPS - EAM, Regulatory Affairs and Strategic Services Division

EARLY ACCESS MEDICINE PROGRAMS CCPS can support you with a full service approach to EAM programs, commencing with strategic design, regulatory consultancy and execution of submissions to the relevant authorities, through to day to day access management as well as global logistics. Our infrastructure in both the USA and Europe provides a strong foundation for global operations, along with our strategically situated, audited depots in more difficult to reach regions and countries. REGULATORY AFFAIRS CONSULTANCY & STRATEGIC SERVICES Our consulting group can offer full service regulatory, development and market access consultancy on a global basis. With offices in the USA and Europe we have extensive knowledge of the regulations and guidelines across all regions with regard to product and device development, all phases of clinical trials, approval and post-market activities. Our list of services include (but are not limited to):- • Product Lifecycle Support • Post-approval • Scientific and Medical Communications • Clinical Development • Strategic Product Development • Strategic Consulting • Product Portfolio Evaluation • Due Diligence • Market Application Preparation & Submission • Protocol Design • CRO Support CANNABIS AND CBD CCPS Strategic Services Group has over 30 years of consulting experience in the supplement and nutraceuticals space, with extensive recent experience in the ever changing and growing Medical Cannabis and CBD industry. We have been involved on the legislation side helping to craft and guide regulations, have been involved in designing studies using cannabinoid products for mainstream diseases, through to managing the global legal and regulatory framework to get medical and scientific based products cleared and registered. FOR MORE INFORMATION ON ANY OF THE ABOVE, CONTACT Angela Bonich (based in Europe) or Adam Mandel (based in the USA) to discuss your global needs.