What is Drug Master file (DMF)?
A Drug Master File (DMF) is a confidential, detailed document submitted to the U.S. Food and Drug Administration (FDA). It […]
A Drug Master File (DMF) is a confidential, detailed document submitted to the U.S. Food and Drug Administration (FDA). It […]
The Indian pharmaceutical industry is undergoing a significant transformation with the introduction of the revised Schedule M under the Drugs
In the pharmaceutical, cosmetics, and medical device, regulatory dossier plays a very significant role in securing registration and product approval
Electronic common technical documents (eCTD) has become global standard for regulatory submissions. eCTD submission has revolutionized the process of drug
Common technical document (CTD) is a harmonized format of documents that is recognized globally across the world for submission of
If you are looking for authorized agent or representative for your medical device registration, you are on right platform. Medwisdom
If you are manufacturer or distributor, looking for manufacturing license for your Medical Device, this guide will help you to
Regulatory Affairs is the crucial department for Pharmaceutical, Medical Device, Cosmetics, Herbal, and Food Industry that must comply with the