GMP and Schedule M Audit Service for Pharmaceutical Facilities

by Sudhriti M | Mar 5, 2025 | Pharmaceutical

All pharmaceutical manufacturing facilities in India are required to comply with the Schedule M guidelines. The guidelines are intended to change the way pharmaceuticals are manufactured in India bringing them at par with global standards. However, ensuring compliance...

Starting an IVD Manufacturing Plant in India: Your Quick Guide

by Sudhriti M | Jan 31, 2025 | Medical Device

In this blog, we have curated a detailed guide for starting an IVD manufacturing plant in India. Additionally, we have discussed the necessary CDSCO license required for setting up an IVD manufacturing facility. What are IVDs? IVDs or in vitro diagnostic devices are...

List of Refurbished Medical Equipment for Import: Key Conditions

by Sudhriti M | Jan 29, 2025 | Medical Device

In this update, we have provided the revised list of refurbished medical equipment for import provided by the Centre. Additionally, we have listed the major conditions for importing refurbished medical equipment into India. Revised list of refurbished medical...

India Rejects IVD Clinical Trial Waiver: Latest IVD Guidelines

by Sudhriti M | Jan 29, 2025 | Medical Device

In-vitro diagnostic devices (IVDs) are instruments, reagents, or systems used to diagnose a disease or other health conditions. IVD tests are usually performed in test tubes or other similar equipment outside the body. Moreover, the tests can be performed using...

5 Key Changes in Revised Schedule M: A Comprehensive Guide

by Sudhriti M | Jan 27, 2025 | Pharmaceutical

Significant changes in Revised Schedule M guidelines have been introduced to safeguard patients and improve the Indian pharmaceutical industry’s reputation. These new guidelines are aimed at changing the way pharmaceuticals are manufactured in India. For further...