Establishment of Regulatory Affairs Team and Finalization of 40 SOPs

The client, a U.S. based pharmaceutical company, had minimal understanding about Regulatory submissions and didn’t had a Regulatory team. They approached Freyr to seek support to establish the Regulatory affairs departmental procedures, practices, Gap Analysis of the existing ANDA and provide possible queries from the FDA, Regulatory consultation and strategic support.          

Read the case study to know how Freyr established the Regulatory affairs team and 40 departmental SOPs. Learn how Freyr offered training on content and format of ANDA, MAPP ANDA checklist, refuse to receive guidelines.