An India-based leading Active Pharmaceutical Ingredient (API) and intermediates manufacturing company reached out to Freyr to seek Regulatory support with the filing of Drug Master File (DMF) submission to the CDSCO. As part of the dossier compilation process, the customer encountered certain challenges while implementing the standard format in the documents as per the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) specifications.
Freyr’s Publishing & Submissions team managed the client’s integrated Regulatory data and submission process and delivered high-quality DMF submissions to the CDSCO within the stipulated time frame.
Learn how Freyr assisted the customer in filing accurate and timely DMF submissions to CDSCO. Download the proven case.