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Premier Research’s regulatory affairs experts will help you navigate the daunting maze of regulations and guidelines. The Regulatory Affairs Group at Premier Research consists of individuals with intimate working knowledge of both the FDA and European regulatory agencies. We can advise you on the most efficient way to design and conduct your development program to maximize your success during all phases, from pre-clinical to post-approval. We can also help you develop strategies and employ tactics to deal with emerging regulatory issues and business opportunities that arise during the product lifecycle.
Premier Research understands the critical importance of complete and accurate regulatory submissions. We will work with you to plan, prepare and submit both global and local submissions.
Services- Regulatory Consulting
- Regulatory Operations
- Electronic Submissions/eCTD
- United States Authorized Representative
- EU Legal Representative
- EU CTA Applicant
- EU Registered Company for Marketing Authorization Applications
- Regulatory Agency Liaison
- Regulatory Due Diligence
- Device Classification and Strategy
- Critical Literature Review
- CE Mark Process
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