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Professional Toxicology Services
"TGen TD2 provides a broad range of regulatory expertise and services with integrated project management to ensure that client programs run seamlessly into clinical development..."
TGen Drug Development (TD2)
Stephen Gately Ph.D, President & Chief Scientific Officer
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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