A generic pharmaceutical company based in India was looking for an established Regulatory service provider to perform gap analysis and draft Modules 1, 2.3, and 3 in compliance with RTR and FDA requirements. Freyr was chosen to assist with the strategic planning and with qualified resources to meet associated Regulatory milestones.
Decode how Freyr enabled the client by providing comprehensive support to meet the Regulatory requirements and obtain approval of the ANDA.
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