Ajay Kumar

Regulatory Compliance & Licensing Specialist (Drugs | Medical Devices | Cosmetics | Telecom (WPC ETA) | Environmental – EPR)

With 10+ years of hands-on experience in India’s regulatory landscape, I help manufacturers, importers, and service providers navigate complex licensing and compliance processes—efficiently and accurately.

Core Specializations

• Pharmaceutical & Drug Licensing (CDSCO & State): Expert in securing Form 20/21 licenses and renewals, with a robust record of approvals.
• Medical Device Registration: Proven experience with NSNM and MD-41 filings, including technical dossier preparation and regulatory strategy for CDSCO.
• Cosmetics Import & Licensing: Skilled in Form 42/43 submissions via the SUGAM portal; adept at packaging, labeling, and Indian Standards compliance.
• Telecom / WPC ETA Certification: Thorough knowledge of Wireless Planning & Coordination norms—supporting electronics and telecom manufacturers through all stages of ETA certification.
• Environmental Compliance (EPR): Hands-on experience in EPR applications under CPCB e-waste, plastic waste, and extended producer responsibility frameworks.

Insights Written By Ajay Kumar

CDSCO Medical Device Registration Checklist: Compliance Simplified

For anyone wanting to produce or distribute a medical device in India, knowledge of CDSCO medical device registration is absolutely essential. The CDSCO is in charge of examining medical devices and guaranteeing their quality and safety in India. Its primary duty is to make sure that every medical device sold or offered in the nation meets the necessary safety, efficacy, and quality standards. This blog will explain the CDSCO guidance and the medical device registration process in India.

What Is a WPC ETA Certificate & How to Get It in India

Wireless technology adoption is gaining speed quickly. Wi-Fi routers, Bluetooth speakers, wireless headphones, and watches have become part of our daily activities. India’s wireless audio device market generated $4.36 billion in 2023. It is projected to reach $14.63 billion by 2030, growing at a strong annual rate of 18.9%.

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