PRA’s global team of regulatory experts offers competitive product development plans, rapid study start-up consultation and effective submissions strategies that support early clinical trial development, product registration and late phase trials. Regulatory Affairs services include:
- Global regulatory consulting services and strategy development for the approval and registration of pharmaceuticals, biologics, generics, biosimilars and medical devices
- Regulatory support to global clinical trials—from Phase I-IV
- Study start-up consultation
- Preparation and coordination of Clinical Trial Applications and INDs
- Consultation and support for Orphan Drug, Fast Track and Pediatric Applications
- Consultation and support for Marketing Applications including CTD format
- Agency liaison and meeting coordination and representation
- Support to sponsors for all interactions with regulatory authorities
- Global regulatory intelligence
- Clinical supplies labeling consultation
- Labeling support: physician and patient text
- Import license applications
- Maintenance of applications
- End-of-study activities
- Gap analyses and assessment of scientific and technical data for various submissions/applications
- Due diligence assessments
