Utility Navigation About Contact Locations Preclarus® Menu Home Services PPD® Consulting Product Development Pharmacology/Toxicology Share this All Services Early Development Clinical Development PPD® Biotech Functional Service Partnerships PPD® Laboratories Post-Approval PPD® Consulting Product Development Pharmacology/Toxicology CMC Consulting Therapeutic Area Consulting Regulatory Affairs Biosimilar Development Adaptive Trial Design Pediatrics Cardiovascular Outcomes Global Quality and Compliance Medical Devices Technology, Innovation & Performance Industry Expertise Pharmacology/Toxicology Pharmacology/toxicology consultants design and implement comprehensive nonclinical plans to enable successful product development from early discovery through post-approval lifecycle management. PPD’s nonclinical team has experience with a variety of compound types (small molecules and biologics, including biosimilars), targets, routes of administration and therapeutic areas. PPD’s 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 Provide literature-based toxicological assessments of extractable/leachable studies and devise strategies to support manufacturing changes and to identify/qualify impurities and degradation products 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 Support 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 nonclinical development scientists include American Board of Toxicology-certified and European Registered Toxicologists with advanced degrees and backgrounds in small, mid-size and large pharmaceutical and biotechnology companies, nonclinical contract research organizations and academia. Contact Us Connect With Us We want to hear from you Investigators Needed Register in PPD's Database Stay Connected RSS Twitter LinkedIn Facebook SERVICES Early Development Clinical Development PPD® Biotech Functional Service Partnerships PPD® Laboratories Post-Approval PPD® Consulting Technology, Innovation & Performance Industry Expertise Event Calendar THERAPEUTIC AREAS Cardiovascular Critical Care Dermatology Endocrine and Metabolics Gastroenterology Hematology & Oncology Immunology Infectious Diseases Neuroscience Ophthalmology Rare Diseases Respiratory Urology Vaccine Development PARTICIPATE IN A TRIAL Austin, TX Clinical Trials Las Vegas, NV Clinical Trials Phase II-IIIB Clinical Trials Become a Clinical Trial Investigator NEWS & EVENTS PPD In The News News Media Kit Event Calendar ABOUT CAREERS SITE MAP Contact Legal Notices Modern Slavery Transparency Statement Privacy Policy © 2017 Pharmaceutical Product Development, LLC. All rights reserved.