Fast-track your agent through regulatory checkpoints and into clinical trials with exclusive consulting from our experts in Chemistry, Manufacturing and Controls (CMC) and Pharmacology/Toxicology. And keep work running smoothly with a dedicated team led by an experienced project manager whose primary responsibility is to make sure your timelines stay on track.
Chemistry, Manufacturing and Controls (CMC) Consulting
Whether you’re shepherding forward research for small molecules, biologics, peptides, antibodies or combination products, you can access diverse and expert consulting from our CMC experts. With decades of years of industry experience, we offer counsel related to research and development, manufacturing, quality systems, physical and chemical characterization, preformulation, formulation, technology transfer to manufacturing (GMP) and product line extension.
Pharmacology and Toxicology Consulting
Access these resources from our pharmacology and toxicology experts—who themselves hold more than 20 years of industry experience in all aspects of preclinical drug development:
- Support with 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
- 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
- Establishment of QA/QC documentation systems
- Preclinical study design
- Preclinical and analytical study monitoring