About MedRegX India

What we do

Every regulated product in India answers to a specific authority, and each authority speaks its own language of forms, fees, and timelines. We translate that. Our consultants manage the full lifecycle of an approval: working out which licence you actually need, building the technical dossier, filing on the government portal, answering the queries that come back, and holding the file together until the certificate is issued.

Our core practice areas cover medical devices and IVDs through CDSCO compliance, quality systems like ISO 13485 certification, US market entry through FDA 510(k) submissions, product certification via BIS certification, environmental obligations through EPR registration, food and supplement licensing under FSSAI, and accredited product testing. Whether you are launching a single device or setting up a manufacturing plant from scratch, there is a service here mapped to it.

How we work

Most regulatory delays are not caused by the government — they are caused by incomplete files. A dossier that is missing one test report, or that classifies a device in the wrong risk class, gets stuck in a query loop that can add months. We front-load that work: classification first, gap analysis second, and a clean submission third. That is why our applications clear technical review far more often on the first attempt.

We keep the process transparent. You get a clear scope, a realistic timeline, and one point of contact who knows your file — not a call centre. When a query lands from CDSCO, BIS, or the FDA, we draft the response and keep the clock moving rather than letting it sit.

Why companies choose MedRegX

Regulatory work rewards experience, because the rules are written down but the practice is not. Knowing which reviewer wants which annexure, how a Plant Master File should actually read, or when a Non-Specified Food approval is worth the wait — that judgement only comes from having filed hundreds of these applications.

• A strong technical-approval record — most dossiers clear review without rejection.
• Direct liaison with regulatory authorities, so queries are handled quickly and correctly.
• Transparent, flat-fee scoping with no hidden government-coordination charges.
• End-to-end coverage — from feasibility and plant setup to licence, testing, and post-approval changes.
• Pan-India service delivered from Dadri, Gautam Buddha Nagar (Delhi NCR), Uttar Pradesh.

Industries we serve

We support the medical device industry, the pharmaceutical industry, the cosmetic industry, the food industry, the environmental sector, and the chemical industry. Each carries its own regulator and its own rulebook, and each has a dedicated team here that lives in those rules day to day.

A moving target we watch for you

Indian regulation does not stand still. The Medical Devices Rules keep pulling new categories under licensing, CDSCO revises its classification lists, BIS adds products to compulsory certification, and CPCB tightens EPR targets almost every year. A licence that was compliant last year can quietly fall out of step. Part of our job is to watch those changes so your product stays sellable — not just approved once, but kept current through renewals, amendments, and re-testing.

That long-term view is why many clients stay with us well past their first approval. Once your file is in order, keeping it that way is far cheaper than rebuilding it under pressure when an inspector or a customs officer asks for a document you do not have. If you are weighing a new product launch, a plant expansion, or entry into a new market, the earliest, cheapest regulatory money you will ever spend is a conversation before you commit — talk to our consultants and we will map the path before you build it.