The client was an Indian pharmaceutical company specializing in generics. It was looking for support in the filing of meeting requests to the USFDA for an ANDA. One of the challenges in this project was the need for making zero defect submissions in lesser time. Freyr engaged an expert team that supported in the lifecycle management of all the client’s products and ensured timely submissions. Freyr validated the documents and replaced them in the eCTD format while taking care of the client’s end-to-end publishing needs.
Know more about how Freyr made on-time submissions to the USFDA and ensured that the client met all the Regulatory requirements in a compliant manner. Download the proven case.