Utility Navigation About Contact Locations Preclarus® Menu Home Services PPD® Consulting Product Development CMC Consulting 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 Chemistry, Manufacturing and Controls (CMC) Consulting PPD® Laboratories' chemistry, manufacturing and controls (CMC) experts provide regulatory guidance in setting specifications, method development and validation and also conduct stability studies. In addition, we identify contract manufacturers, arrange contract laboratory services and conduct good manufacturing practice (GMP) audits, as well as extensive consulting services. Expertise in All Areas of CMC Development PPD® Laboratories' CMC team has experience with a variety of compound types (small molecules and biologics, including biosimilars), dosage forms, routes of administration and therapeutic areas. Our highly trained staff has advanced degrees in a variety of scientific disciplines, such as chemistry, biochemistry and pharmacy, and work experience in large pharmaceutical organizations, as well as in virtual and start-up biotech operations. Product Development and Regulatory Strategies Fast-to-clinic and first-in-man strategies to minimize drug use via compounding in clinic Regulatory documentation and due diligence reviews prior to compound purchase CMC regulatory strategies and advice from lab bench to pharmacy shelves Formulation, analytical and manufacturing process development advice on formulations and drug delivery approaches CMC Regulatory Services Preparation and review of regulatory submissions, including: Investigational new drug (IND) Clinical trial authorization (CTA) Investigational medicinal product dossier (IMPD) New drug application (NDA) Marketing authorization application (MAA) Abbreviated new drug application (ANDA) Authoring of annual reports, drug master files, dossier amendments and supplements Preparation, publication and submission of electronic common technical documents (eCTD) applications Direct interactions and negotiations with U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and national agencies Active Pharmaceutical Ingredients (API) and Clinical Trial Material Sourcing and Management Scientific/project-specific site visits and GMP audits to evaluate vendor staff and facility capabilities necessary to execute the program Interpretation of scientific results Alternative approaches to keep clinical development programs on schedule Advice on setting appropriate specifications, assigning product shelf life and conducting failure investigations Customized Solutions for Small Virtual Companies Full regulatory affairs support Access to preclinical toxicologists and pharmacokineticists Access to clinical therapeutic area experts Full CMC development of drug substance and drug product 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.