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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.
United States- Investigational New Drug Applications (INDs)
- Exploratory INDs
- Special Protocol Assessments
- IND Amendments
- IND Safety Reports/Annual Reports
- FDA Meeting Request/Information Packages
- New Drug or Biologic Applications
- Supplemental NDAs/BLAs
Europe- Clinical Trial Applications (CTAs)
- Marketing Authorization Applications (MAAs)
- EU MAA Registration Procedures
- EMEA and National Scientific Advice Procedures
- CTD reformatting
- Variations
- Renewal Applications
In addition, Premier Research has industry-leading expertise in submissions and strategies for Medical Devices including: - Setup of US requirements 510k, PMA, HDE
- Pre-IDE meetings
- IDE submissions
- Writing of 510K, PMA, HDE
- Classification process
- Conformity assessment dossiers
- Risk analyses
- Critical literature reviews
- Pre-clinical requirements, selection and collaboration with pre-clinical laboratories for global approach EU/US/Japan
- Clinical regulatory including notifications to Competent Authorities and data protection submissions
- Pre-consultations processes with drug authorities for combination products
- National dossiers for biologics/tissue engineered products
Services- Regulatory Consulting
- Regulatory Submissions
- Electronic Submissions
- Regulatory Agency Liaison
- Regulatory Due Diligence
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