Cmed’s Regulatory Affairs team is dedicated to understanding the regulatory requirements that impact your study and delivering against them, on schedule and within budget.
At the launch of your project, we work with you to develop a comprehensive regulatory submission strategy, including detailed requirements per country and a complete listing of all needed documents, outlined in our Regulatory Project Plan. We offer full development or review, as required, of key documents, including IB, IMPD, ICF and labels, ensuring compliance with all relevant requirements.
Regulatory Document Development
- Full informed consent form development; either from your master document or our own ICH compliant global/regional templates.
- Investigator Brochure review and/or development.
- Investigational Medical Product Dossier review and/or development. • Investigational product label review and/or development.
Regulatory Authority (RA) and Institutional Review Board (IRB) / Ethics Committees (EC) Applications
- Full development, compilation, submission and follow-up of applications to RA, IRB/EC as required for clinical study approval.
- Collection and tracking of regulatory documents.
- Projection and tracking of submission and approval status.
Maintenance of Clinical Trial Authorizations Throughout Study Lifecycle
- Preparation, review, submission and follow-up of amendments.
- Study progress reporting to IRB/EC.
- Preparation and submission of End of Trial notifications within required timelines.
Other Supporting Services
- Provision of regulatory intelligence to support submission strategy.
- Act as “Legal Representative” for our non-EU based clients.
- Review of essential documents to support regulatory release of investigational product to site.
Combination products are becoming increasingly common as technological advances help to improve patient compliance – and to create targeted treatments in the emerging context of personalized medicine. Trust Cmed’s experienced team to help you develop your combination products. As products have become more advanced, so has our approach to ensure your commercial success.
Benefits to you
- Our extensive device, drug and biologics expertise helps you identify the optimum regulatory pathway (e.g., single or multiple marketing applications) and market access strategy.
- We can determine the regulatory agency with primary jurisdiction for premarket review and regulation of the combination product – helping you to craft a strategic regulatory plan to support the registration and success of the product.
Cmed provides services at every phase of the pharmaceutical product development lifecycle, with proven expertise in helping customers make the right decisions for success. Biopharma companies which are struggling to complete clinical projects; need help with the correct trial design; or simply want trusted support rely on Cmed to help them achieve their full commercial objectives.
- Our considerable hands-on experience means that we truly understand your development challenges and can help you overcome them.
- We provide both the necessary support to execute prospective strategic plans – as well as to respond to and resolve urgent tactical situations which may arise during development.
- Our cross-functional experts have proven success in getting from concept to commercialization. We bring a global view to development, fueling the engine to drive your success.