One-stop shop CMC and regulatory capability.
We deploy a stable, multi-disciplinary team of CMC experts with the appropriate experience applicable to your API and manufacturing process and product. In cooperation with your internal specialists, your DS InPharmatics team will review data, batch records, validation procedures, and conduct cGMP audits and manage your products development to ensure your contract manufacturers and laboratories and development program are in compliance with regulatory requirements.
CMC Program Management includes:
- Regularly scheduled project team meetings and teleconferences
- Direct access to scientific and regulatory experts
One-stop shop CMC and regulatory capability. Rather than spending your time trying to manage and integrate multiple consultants, contract manufacturers and laboratories, DS InPharmatics’ CMC Team approach provides you with a single source of scientific, technical and regulatory expertise.
We ensure that your drug development program is complete and thoroughly aligned with your regulatory strategy. DS InPharmatics’ integrated CMC regulatory capability can translate reports and data into submission ready content.
Avoid costly product development and approval delays due to CMC issues. In today’s complex and changing regulatory environment, DSI can enhance your operational capability and ensure smooth sailing from Phase 1 all the way through to NDA or BLA submission and approval.