An India-based active pharmaceutical ingredients manufacturer sought Regulatory support to prepare an ASMF cover letter as per the EU ASMF requirements. They wanted to publish the ASMF into eCTD format and submit it to the EU (EE, DE, PT, LT & LV). Due to a lack of awareness of the format requirements, the client reached out to Freyr to overcome several operational challenges.

Learn how Freyr prepared, converted, and submitted ASMF cover letters aligning with EU Regulatory requirements.