Regulatory CMC expertise for drug development from discovery to manufacturing
Our regulatory CMC team provides expertise in all areas of product development, from small molecules to biologics. We provide regulatory advice and compile your application for drug substances, pharmaceutical excipients, packaging materials, and drug-device combination products.
We offer regulatory advice and compile your application using phase-appropriate standards, from early development through manufacturing, to accelerate your project and advance your product to the clinic.
We specialize in creating scientific and technical reports using a dossier-centric approach. This ensures consistency, completeness, and readability while keeping the final application in mind.
Our reports are designed to meet regulatory requirements and provide comprehensive documentation for your drug development program.
The following reports are essential in the pharmaceutical industry and play a significant role in ensuring product quality, safety, and efficacy:
The following documents are integral for ensuring the safety and efficacy of drug substances:
We provide comprehensive PAR justification reports that demonstrate the acceptable ranges for critical process parameters, ensuring robust manufacturing processes and regulatory compliance.
Experienced regulatory professionals with deep understanding of global requirements.
End-to-end CMC support from early development through commercialization.
Proven track record of successful regulatory submissions and approvals.
Contact our CMC documentation team to discuss your regulatory needs and how we can support your drug development program.