Regulatory Affairs
For assistance with regulatory affairs you do not need to look further. Our team is highly-experienced and well-trained. We can help you with:
- Common Technical Document (CTD) format dossiers (clinical – and integrated summary sections): CTD format section 2.2, 2.3, 2.5 and review of 2.7
- New Drug Applications (NDAs) (clinical – and integrated summary sections)
- Investigational New Drug (IND) applications and annual updates
- Pre-FDA meeting briefing documents
- Integrated written and tabular summaries
- Reports and executive summaries
- Clinical expert statements
- Query statements and management
- Data management
- Pharmacovigilance
- Biostatistics
- Medical & Scientific writing
- Regulatory Affairs
- Scientific communications
