FDA updated the guideline for Providing Regulatory Submissions in Electronic Format to reflect that the requirement for Type III drug master files (DMFs) to be filed electronically takes place 60 months after May 5, 2015.
This implies that holders of type III DMFs must submit in eCTD format by 5th May 2020.
Asphalion has extensive experience with preparation of DMFs in electronic format.
For more information please contact [email protected]
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As Brexit is quickly coming closer, the CMDh has published an updated version of the Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP in December 2020.
Asphalion is excited and proud to officially welcome Javier Febrero Alija to its team as Regulatory Information Manager, expert in Data Management and RIMS.
We wish you Happy ‘Xmas, Prosperous New Year and Health for you and your loved ones.
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