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What is Module 2.4 Nonclinical Summary It is the integrated and critical assessment of the pharmacologic, pharmacokinetic, and toxicologic evaluation […]

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