Regulatory/Submission-Level Document Preparation and Review
- Preparation of submission-ready CTD-format Module 2 Tabulated and Written Summaries for pre-IND-, IND- and NDA-stage products
- Preparation of information packages supporting FDA Special Protocol Assessment of carcinogenicity study protocols
- Preparation of nonclinical components of key regulatory documents including Investigator's Brochures, periodic reports, expert reports, global product labeling (package inserts, patient product information leaflets) and product monographs
- Expert review of draft submission-level documents identifying areas of vulnerability with respect to nonclinical data
