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

Step-by-Step GST Registration Process for New Businesses

All new Indian businesses that intend to sell goods or services are bound to follow government regulations. One such regulation is GST registration. GST registration in India facilitates your business to lawfully impose tax and grant input tax credit. It also helps build trust with your customers.

State-Wise Procedures and Compliance Checklist for Shop and Establishment Act

Starting any business requires some legal steps. One important legal step in India is the Shop and Establishment Act registration. This applies to most businesses, from small shops to large offices. Every state has its own rules, but the main purpose is the same, which is to regulate working hours, employee rights, and workplace conditions.

Eligibility Criteria & Documents Needed for MSME Registration

Starting and running a small business is not easy. You face numerous challenges, including slow payments and tough competition. But if you run a micro, small, or medium enterprise in India, MSME registration can help. This government process gives your business legal status and access to special support like loans, tax help, and buyer protection.

Tips for Ensuring a Smooth NSNM Medical Device Compliance Audit

An NSNM compliance audit can prove to be difficult for low-risk medical device manufacturers if they lack knowledge of the processes. A smooth NSNM medical device compliance audit keeps your team compliant with all CDSCO regulations and stays prepared for audits in India, and remains secure and legally compliant.

Documents Checklist for MD41 Medical Device Import Registration

Why must any firm begin with steps to get a permit called MD-41 when they aim to become a wholesaler of health items in India? If you want to legally sell or stock medical devices in India, the government requires an official paper set that proves you meet storage and technical staff rules.

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