Streamlining CMC for Manufacturing Changes

Challenges

The project posed a multifaceted challenge due to the intricate nature and volume of manufacturing changes. A high degree of interdependence among these changes necessitated a comprehensive submission strategy. Furthermore, a due diligence assessment of the dossier was imperative, as unforeseen issues arose during the manufacturing changes, demanding additional interactions with regulatory authorities. The involvement of third-party stakeholders, including Contract Manufacturing Organisations (CMOs) and external advisors, further compounded the complexity.

DLRC’s Solution

To navigate these intricate challenges, DLRC adopted a collaborative approach, seamlessly integrating project management, CMC expertise, and our regulatory operations teams. This dynamic collaboration was instrumental in meeting the demanding project requirements.

DLRC prioritised timely and transparent communication with the client, third parties, and regulatory authorities. This proactive engagement resulted in the development of a clear and well-coordinated regulatory submission strategy. DLRC worked with the regulator to negotiate an effective grouping of variations across multiple licences  which comprised of up to 39 changes.

DLRC’s dedicated CMC team conducted comprehensive reviews and provided expert advice on various aspects of the necessary dossier updates. Their input significantly enhanced the value and robustness of the submission packages. DLRC’s rigorous quality system ensured impeccable document traceability and streamlined submission management across diverse teams, ensuring seamless execution.

Outcome

DLRC’s unrivalled CMC and regulatory expertise culminated in an coherent regulatory strategy that exceeded expectations. Only one minor request for further information (RFI) was received from the regulatory authorities. Demonstrating our proficiency, DLRC promptly responded to this RFI. As a testament to the quality of our work, full approval swiftly followed, marking a resounding success for our client and DLRC’s dedication to excellence.

The successful collaboration between DLRC and our client has not only ensured the swift approval of crucial manufacturing changes but has also laid the foundation for future success. Our client can now move forward with implementing their desired manufacturing process changes efficiently and without delay.

If you too seek the support and expertise of DLRC in your regulatory endeavours, we invite you to reach out to us at hello@dlrcgroup.com. Together, we can turn your regulatory challenges into successes.