CDSCO Regulatory ApprovalsMedRegX
Expert guidance through CDSCO regulatory pathways for drugs, cosmetics, and medical devices — from clinical trials to marketing authorizations.
CDSCO Approved
NABL Accredited
BIS Certified
MedRegX – India's Top-Rated CDSCO & BIS Certification Consultant for ISI Mark, CRS & FMCS Services
MedRegX India Pvt Ltd is a premier regulatory consulting firm dedicated to helping businesses navigate the intricate compliance requirements of the Indian market. With over 6 years of expertise, we serve as a strategic partner for global and domestic manufacturers.
- India's leading multi-sector regulatory consulting firm since 2018
- 800+ successful regulatory projects across all industries
- Team of 30+ expert regulatory consultants, scientists & lawyers
- Authorized Indian Representative (AIR) for global medical device companies
Comprehensive Regulatory Compliance Solutions
We manage the certifications and approvals that regulated products need to reach the market — handled end to end, from application to certificate.
ExclusivePartner
The Official Regulatory Backbone for Clove Dental.
MedRegX India manages the entire nationwide regulatory infrastructure for Clove Dental—handling all compliance, manufacturing, and global imports.
Managing Every Technical Facet Nationwide
Why Leading Enterprises Trust Us.
6+ Years Expertise
Over 6 years of specialized experience in Indian regulatory affairs across all sectors.
Fast-Track Processing
Streamlined workflows and government liaison for faster approval timelines.
100% Compliance
Zero compromise on compliance — every submission meets regulatory standards.
Dedicated Team
30+ regulatory experts, scientists, and legal professionals on your side.
Pan-India Coverage
Offices across major Indian cities with expertise in state-level regulations.
24/7 Support
Round-the-clock client support with dedicated account managers.
Our Proven Regulatory Process
Initial Consultation
Regulatory Assessment
Documentation Planning
Submission & Filing
Query Resolution
Approval & Handover
Renewal & Monitoring
Ongoing Compliance
Industries We Specialize In
Deep domain expertise across six regulated industries with customized compliance strategies for each sector.
Companies That Trust MedRegX
From cutting-edge biotech to established healthcare, MedRegX empowers companies to navigate regulations seamlessly.
Empowering industry leaders across healthcare & beyond.
What Our Clients Say About Us
Real stories from real clients — see why India's top companies trust MedRegX for their regulatory needs.
"MedRegX handled our Class B medical device import registration end-to-end. Their CDSCO liaison team resolved a deficiency query in just 4 days — something we could not manage in months. Highly recommended for any device manufacturer."
Regulatory News & Updates
Stay ahead with the latest regulatory updates, compliance guides, and industry insights from our expert team.
Frequently Asked Questions
Find answers to the most commonly asked questions about our services and regulatory processes.
Ready to Start Your Regulatory Journey?
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Your End-to-End Regulatory Compliance Partner in India
MedRegX India Pvt Ltd helps manufacturers, importers and brand owners get their products legally approved for the Indian and global markets. From our base in Dadri, Gautam Buddha Nagar (Delhi NCR), Uttar Pradesh, we manage the full compliance lifecycle — from medical device registration and BIS certification to environmental and food licensing — for clients across Delhi, Noida, Mumbai, Bengaluru, Chennai, Ahmedabad, Pune and beyond.
Regulation in India is detailed, and it moves. Whether you need a single licence or a plant built to spec, the difference between a smooth launch and an expensive stall is almost always the same thing: a clean, correctly-classified dossier filed the first time. That is what we do — across medical devices, pharmaceuticals, cosmetics, electronics, food and the environmental sector.
Regulation in India is detailed, and it moves. The difference between a smooth launch and an expensive stall is almost always the same thing: a clean, correctly-classified dossier filed the first time. Every regulated product answers to its own authority, with its own language of forms, fees and timelines — we translate that and front-load the work so nothing stalls at the portal.
Classification first
We pin the exact licence and risk class before anything else is filed.
Gap analysis
We find what the dossier is missing before the regulator does.
Clean submission
A complete file that clears technical review on the first attempt.
Why businesses choose MedRegX
Experience that clears review
Regulatory work rewards experience, because the rules are written down but the practice is not. Our team has filed hundreds of applications with CDSCO, BIS, the FDA, FSSAI and CPCB, so we know which reviewer wants which annexure, how a Plant Master File should read, and where dossiers usually get stuck. That judgement is why our applications clear technical review far more often on the first attempt — and why clients treat us as a long-term compliance partner rather than a one-time filing service.
Transparent pricing, fast turnaround
We keep the process transparent: a clear scope, a realistic timeline, flat-fee pricing with no hidden government-coordination charges, and one point of contact who knows your file. Speed matters as much as accuracy — a CDSCO import licence can take six to nine months and a BIS certification 30 to 45 days after testing, but every timeline stretches when queries go unanswered. Our query desk turns regulator letters around in days rather than weeks, which is often what decides whether a launch stays on schedule.
Every regulated sector covered
We support every major regulated sector. The medical device industry relies on us for CDSCO licensing and quality systems; pharmaceutical manufacturers for drug licences and GMP plant setup; cosmetic brands for import registration and labelling; food and supplement companies for FSSAI and nutraceutical compliance; and the electronics, chemical and environmental sectors for BIS, PESO, testing and EPR. Whatever you make, there is a compliance path mapped to it — and someone here who files it every week.
Your compliant presence in India
For overseas manufacturers we also act as your Authorised Indian Representative, giving you a compliant, responsive presence in India without a local office. If you are planning a product launch, a plant expansion, or entry into a new market, the earliest and cheapest regulatory money you will ever spend is a conversation before you commit — talk to our consultants for a free assessment of exactly what your product needs to reach the market — the first time, and every renewal after.