The client was an India-based leading pharmaceutical product-development organization and was looking for Regulatory support in the submission of DRL-Quality response to the FDA. Challenges such as a lack of understanding in the Regulatory requirements for the response and a dearth of resources in its preparation were a part of this project. Freyr conducted a thorough gap-analysis of the technical documents presented by the client and identified the risks in the same. Freyr was able to update and finalize the DRL-Quality response on time and help the client in keeping up their business objectives.
Explore how Freyr was able to offer technical support to the client in the submission of DRL-Quality response to the FDA in a compliant manner. Download the proven case.