Pharmacology / Toxicology

Pharmacology/toxicology consultants in our global regulatory affairs department work closely with pharmacokineticists in our clinical pharmacology group to design and implement comprehensive nonclinical plans to enable successful product development from preclinical through post-approval lifecycle management.

Our nonclinical development scientists, including American Board of Toxicology-certified and European Registered Toxicologists, provide assistance with program and study design; obtaining competitive bids with comparisons based on critical milestones; and oversight and monitoring of nonclinical studies. GCR’s nonclinical team has experience with a variety of compound types (small molecules and biologics, including biosimilars), targets, routes of administration and therapeutic areas

Our nonclinical development experts work with clients to:

  • Design streamlined, efficient pharmacology/toxicology programs to support the intended dose, route and duration of treatment in the clinic and enable successful regulatory filings
  • Identify and address key pharmacology and toxicology issues unique to the compound, the indication or the patient population, in accordance with relevant regulatory guidances
  • Provide advice on budgets, timelines and global regulatory requirements
  • Design nonclinical studies, prepare protocols, monitor studies, and review data and reports
  • Prepare and review nonclinical summaries for global regulatory submissions, including but not limited to IND/CTA and NDA/BLA/MAA and meeting packages
  • Provide expert toxicology representation before regulatory authorities
  • Develop gap analysis of nonclinical packages with assessments of strengths, weaknesses, opportunities and threats.

GCR’s nonclinical regulatory team also supports business development activities by leading nonclinical tasks for due diligence activities, preparing and reviewing nonclinical packages for partnering/out-licensing efforts, and representing companies sharing global programs and strategies to potential partners/outside investors

Our toxicologists also enable successful product development and manufacturing by providing literature-based toxicological assessments of extractable/leachable studies, and devising strategies to support manufacturing changes and to identify/qualify impurities and degradation products.