CMC and Pharmacology/Toxicology Services
TD2 offers expertise and consulting in Chemistry Manufacturing and Controls (CMC) and Pharmacology/Toxicology. Our experts are responsible for delivering high quality regulatory strategies to ensure an efficient transition into clinical trials. All activities are overseen and coordinated by project managers. Services and expertise include:
Chemistry Manufacturing and Controls (CMC) Consulting
TD2's CMC experts have over 25 years of industry experience with broad-based management oversight of technical operations concerning development of drugs, biologics, peptides, antibodies and combination products. This expertise includes R&D, Manufacturing, Quality Systems, Physical and Chemical Characterization, Preformulation, Formulation, Technology Transfer to Manufacturing (GMP) and Product Line Extension.
Pharmacology and Toxicology Consulting
TD2's Pharmacology and Toxicology experts each have over 20 years of industry experience with all aspects of preclinical drug development. Specific areas of expertise includes design and implementation of drug development plans for pharmacology, pharmacokinetic and toxicology studies, direction of preclinical programs for product development for small molecules, proteins, peptides, antibodies, drug-delivery systems and cell based therapies. These experts are responsible for coordination of multi-disciplinary product development activities, oversight of regulatory documents and interaction with regulatory agencies, management of studies at contract facilities, analytical methods development, set up of QA/QC documentation systems, preclinical study design and monitoring of preclinical and analytical studies.