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.