Pharmacology/toxicology consultants in PPD’s global regulatory affairs department work closely with pharmacokineticists in PPD’s clinical pharmacology group to design and implement comprehensive non-clinical plans to enable successful product development from preclinical through post-approval lifecycle management.
Our non-clinical 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 non-clinical studies. PPD’s non-clinical team has experience with a variety of compound types (small molecules and biologics, including biosimilars), targets, routes of administration and therapeutic areas
Our non-clinical 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 non-clinical studies, prepare protocols, monitor studies, and review data and reports
- Prepare and review non-clinical 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 non-clinical packages with assessments of strengths, weaknesses, opportunities and threats.
PPD’s non-clinical regulatory team also supports business development activities by leading non-clinical tasks for due diligence activities, preparing and reviewing non-clinical packages for partnering/outlicensing 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.