Increase Affiliate and Partner Engagement to Improve Regulatory Processes

Traditionally, companies distribute a basic document package to their affiliates in non-eCTD markets, leaving local operating companies to finalize and publish the dossier to the relevant health authority. This approach limits downstream visibility and increases compliance risks.

Regulatory thought leaders from 14 companies discussed best practices for planning, preparing, and completing local health authority submission dossiers in a recent community meeting at the Roche office in Basel, Switzerland.

Roche, GSK, Merck KGaA, and SOBI shared how they leveraged increased visibility, clarity of responsibilities, and accuracy with Veeva Vault RIM to improve regulatory processes with affiliates and partners in non-eCTD markets:

• Roche discussed how they reduced end-to-end cycle times in their global content plan dispatch process for Clinical Trial Applications (CTAs) with greater visibility and local affiliate engagement.
• GSK explored the difference between centralized and decentralized regulatory activities and the importance of developing clear roles, responsibilities, and accountability. With a well-communicated and transparent operating model, local affiliates understand “what’s in it for me?” and take a more active role in the process.
• Merck KGaA established a new team of highly trained submission managers by combining the submission project manager and publisher responsibilities to ensure local submission packages are accurate and high quality.

Midsize companies like SOBI face challenges similar to large biotechs / biopharmas with regulatory process management, but often have far fewer resources. As a rapidly expanding biotech, SOBI strategically implemented the full Vault RIM platform to unify and streamline its regulatory processes. Now live with Vault Submissions, Vault Submission Archive, Vault Registrations, and Vault Publishing, SOBI is securing its position at the forefront of efficient and compliant regulatory operations.

To learn more about optimizing affiliate collaboration, register for the 2024 Veeva R&D and Quality Summit in Madrid.