menu
Professional Toxicology Services
"We engage Paracelsus at Aires (and did so at our previous company, Palkion) and have been very pleased with Dr. Furman’s knowledge, expertise, advice, timeliness, and work ethic..."
Aires Pharmaceuticals
Hiroko Masamune, PhD
view all testimonials

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