Regulatory Affairs Consulting
New Drug Application – NDA / BLA
- Form FDA 356h Review
- Form FDA 3397 Review
- Form FDA 3331 Review
- Cover Letter Review
- Patent Information and Certification Review
- Table of Content Review
- Summary of Application Review
- Chemistry Manufacturing and Controls Content Review
- Non-clinical, toxicology and pharmacology data and summaries Review
- Human Pharmacokinetics and Bioavailability Review
- Microbiology Report Review
- Clinical Data Review
- Statistical Data Review
- Case report forms and tabulations Review
- Labeling Proposal Review
- Patent Information Review
- Financial disclosure Review
