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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
Case Studies
Case Study  Supporting FDA Requests
Case Study  Providing Comprehensive Services for Prostate Cancer
Case Study  Developing an Adaptive Design for an Oncology Study
Case Study  Meeting Aggressive Timelines for a New Drug Application
Webinars
 Register for our complimentary pediatric webinars.
Recent News
News  23-Jan-12 Premier Research Names Etienne Drouet Executive Director, Oncology Europe
News  16-Jan-12 Premier Research Names Dr. Colin Hayward as European Medical Director
News  11-Jan-12 Premier Research Names Susan Stansfield, PhD Executive VP, Clinical Development
 See All News
Upcoming Events
Event  03-Feb-12 ICR’s Ethics & GCP Forum
Event  28-Feb-12 ICR Symposium
Event  04-Mar-12 Partnerships in Clinical Trials Conference
 See All Events
 
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