Verta Life Sciences consultants have helped clients register numerous products with the US FDA, EMA, WHO, and regulatory agencies worldwide.
Our CMC regulatory expertise covers all aspects of regulatory approval, including filing IND’s, IMPD’s, NDA’s, BLA’s, MAA’s, SNDA’s, initial regulatory approvals and post-approval amendments for all pharmaceutical, biotech dosage forms and medical devices.
CMC Regulatory areas of expertise include:
- Authoring of Common Technical Document CMC Modules 2 and 3.
- Development of global stability programs.
- Implementation of regulatory solutions to CMC issues and preparation of contingency plans to ensure approval.
- Preparing CMC team members for scientific advice meetings with regulatory authorities such as pre-NDA, End-of Phase 2 and Pre-NDA meetings.
- Communicating directly with regulatory authorities to negotiate and influence CMC project issues that are aligned with business needs.
- Provisions of regulatory strategy to manage CMC changes throughout the development process.
- Participation as CMC regulatory experts on due diligence assessment of in-licensing and joint development opportunities.
CMC Regulatory– case study
The company had planned CMC Post-Approval Change of a controlled release tablet which involved a change in manufacturing site, scale (batch size) equipment and process.
Based on a substantial body of prior knowledge, a hypothesis was developed that process control was the greatest risk in the technology transfer, not the product stability. Two multivariant models were developed evaluating process design space and stability.
The final outcome was that 3 batches of stability were waived resulting in a cost savings of $350K.
The new approach provided a rational for selecting the biobatch, enabled a different approach to process validation and provided for continuous verification, established a foundation for evaluating future changes using product and process knowledge.