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Professional Toxicology Services
"We have had the great pleasure to work with Grace at Paracelsus on ENDECE’s lead oncolytic candidate, NDC-1308, and now consider her to be our “go to” person for toxicology...."
Endece
Dr. James Yarger, CEO
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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