Module 2.4 Nonclinical Summary is the integrated and critical assessment of pharmacologic, pharmacokinetic, and toxicologic evaluation of pharmaceuticals in animals. Safety of novel excipients is also evaluated. View Article
A Drug Master File (DMF) is a confidential, detailed document submitted to the U.S. Food and Drug Administration (FDA) to support drug applications. View Article
The Indian pharmaceutical industry is undergoing transformation with the introduction of revised Schedule M under the Drugs and Cosmetics Rules. View Article
In pharmaceutical, cosmetics, and medical device industries, regulatory dossier plays a key role in securing registration and product approval globally. View Article
Electronic Common Technical Document (eCTD) is now the global standard for regulatory submissions and has transformed the drug approval process. View Article
Common Technical Document (CTD) is a globally recognized harmonized format for submitting pharmaceutical product registration documents. View Article
Looking for an authorized agent or representative for medical device registration in India? Medwisdom provides complete support and guidance. View Article
If you are a manufacturer or distributor seeking a manufacturing license for medical devices in India, this guide explains the complete process. View Article
Regulatory Affairs is a critical department in Pharmaceutical, Medical Device, Cosmetics, Herbal, and Food industries that ensures compliance with laws. View Article
