A USA-based generic pharmaceutical company was looking for a specialized Regulatory service provider to support their gap analysis of technical documents, authoring, updating, finalizing, and submitting CBE-30 activities. Freyr, a pioneer in providing strategic, multidisciplinary Regulatory affairs consulting services worldwide, has collaborated with the client and delivered compliant supplement sections per current FDA requirements.
Decode how Freyr provided the required Regulatory support to ensure to carry out ANDA preparation activities efficiently to achieve compliance as required by US FDA.