"Paracelsus has been an indispensable member of this team since 2007 and is responsible for providing strategic and operational nonclinical safety support to TD2 client programs... "
TGen Drug Development
Stephen Gately, PhD

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