Located in the USA, the client is a fortune 500 global technology and specialty materials company. The company consulted Freyr as they were not able to convert the existing Type II DMFs into electronic eCTD format and submit to the USFDA. When Freyr accepted the project, it had to face several challenges like the client had minimal understanding on technical requirements for type II DMF conversion, on adequacy of existing DMF, and even the response from the client was low.
How Freyr did resolve all the challenges and successfully convert the Type II DMFs into electronic eCTD? Read the case to know more.