"We chose Paracelsus to help us with our first IND application because of Dr. Grace Furman’s prominent reputation in the toxicology arena and her extensive experience..."

CalciMedica

Ken Stauderman, VP Research

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