Fast-track your agent through regulatory checkpoints and into oncology clinical trials with exclusive regulatory affairs 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 program 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 cell-based therapies, you can access diverse and expert consulting from our CMC experts. With decades of industry experience, we offer counsel and regulatory strategy related to vendor selection, RFP management, 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 oncology drug development plans for pharmacology, pharmacokinetic testing and toxicology studies
- Direction of preclinical programs for product development for small molecules, proteins, peptides, antibodies, drug-delivery systems, cell-based therapies, etc.
- 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