Our regulatory professionals offer experienced strategic advice to support and accelerate the achievement of your regulatory milestones.
Regulatory Strategy Consulting
Is your product development plan optimized to provide the most efficient and trouble-free path to approval? If you find it hard to answer this question, you’re not alone. Creating a well-defined roadmap that provides a clear view of the path ahead is a challenge for many companies. Our regulatory consultants can help reduce your time-to-market by designing practical regulatory strategy and development plans, or by reviewing your own plans and recommending specific actions and choices that can save time and resources.
- Product development consulting (scientific, technical and regulatory)
- Expert reports and summaries
- Pricing, reimbursement and transparency dossiers
- Product information preparation
- On-site regulatory services
- Library and information services
Dossiers and Submissions
Our experience in multi-national efforts ensures that you will benefit from our unique combination of local knowledge and global perspective. In Europe, we have prepared Centralized or Mutual Recognition dossiers for numerous clients. IMETICS Regulatory Affairs provided regulatory support to the client and developed all sections of the MAA, including development of all technical sections.
- Clinical Trial Authorizations (IND, CTX, etc.)
- Marketing Authorization dossiers (NDA, MAA, CTD)
- Applications Procedures (EU Mutual Recognition and Centralized)
- Electronic dossiers
- Variations, notifications, renewals, reviews
- Templates for the Common Technical Document (CTD)
- Master Files
- Review of Site Regulatory Packages (SRPs)
- Translation services
- Import licensing
- Project management