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Regulatory and compliance

Regulatory affairs

We take medicines, medical devices and combination products through approval with CDSCO in India, the US FDA and under EU MDR. Then we help you keep the approval.

What it is

In one sentence

We plan your route to approval, prepare the dossier (the full set of documents a regulator reviews), file it, and answer the regulator's questions until the product is approved.

Who it is for

Regulatory and quality heads at pharma, medtech, nutraceutical and FMCG companies. Also founders and university teams filing for the first time.

Problems it solves

What goes wrong, and how we prevent it

  • Round after round of queries

    Most queries come from one cause: documents that do not match the intended use statement (the short, exact description of what your product is for). We lock that statement first and check every document against it.

  • Filings sent back before review starts

    Wrong file names, missing signatures or a contents page that does not match. These are easy to prevent. We check the format before you file.

  • Stuck at classification

    Software and drug-device combination products often stall because nobody decided what kind of product they are. We settle the classification before the dossier is written.

What you get

Deliverables

  • A regulatory route for each market you want to reach
  • CDSCO filings, plus support after approval (changes, renewals and label updates)
  • US FDA strategy for 510(k), De Novo, IND, NDA and BLA routes
  • EU MDR technical files for medical devices
  • Classification and dossiers for software as a medical device
  • A strategy for drug-device combination products
  • Label checks against the rules in each market
  • Support for technology transfer and licences, including wholesale licences
  • Compliance audits, so you are ready for an inspection (see Compliance audits)

How it works

From first check to approval

A CDSCO manufacturing or import licence typically takes 3 to 9 months, including query rounds. It depends on the product's category.

  1. Check where you stand

    We review your product, your documents and your target markets. You get a short gap report: what is ready and what is missing.

  2. Agree the route

    We confirm the product's class and the approval route in each market. We lock the intended use statement.

  3. Build the dossier

    We write or review each document and check it against the intended use. We plan the documents so parts can be reused in other markets.

  4. File and answer queries

    We file through the right portal, such as CDSCO's Sugam portal. When queries come, we answer every point in one complete response.

  5. Keep the approval

    After approval we help with changes, renewals, label updates and inspections.

Regulators and standards

Who we file with

We name the regulator and the rule for each piece of work.

CDSCO (India)
The Central Drugs Standard Control Organisation. India's national regulator for medicines and medical devices. Filings go through its online Sugam portal.
US FDA
The US Food and Drug Administration. We plan 510(k), De Novo, IND, NDA and BLA routes. These terms are explained below.
EU MDR
The European Union's Medical Device Regulation. It sets what a device's technical file must contain.
Medical Devices Rules, 2017 (India)
India's rules for medical devices, including software that counts as a device.
Terms explained
510(k) and De Novo are US routes for devices. IND is the US filing to start trials of a new medicine. NDA and BLA are US filings to sell a new medicine or a biological product.

Proof

We have prepared filings for CDSCO (India), the US FDA, the UK's MHRA, AYUSH (India's ministry for traditional medicine) and FSSAI (India's food safety regulator).

FAQs

Questions we are often asked

A hospital app reminds patients to take their tablets. Does it need CDSCO registration?

Not if it only reminds, schedules and tracks. Then it is not a medical device. It becomes software as a medical device if it recommends treatment, changes doses based on patient data, or reads clinical results. Then it must be registered under the Medical Devices Rules, 2017. The test is simple: does the software's output change a clinical decision?

A clinical thermometer is sold over the counter. Does it still need CDSCO registration?

Yes. Clinical thermometers are notified medical devices under the Medical Devices Rules, 2017. Even the lowest-risk devices (Class A) must be registered on the Sugam portal. They also need BIS compliance and a declaration of conformity. Selling without registration can lead to seizure of stock and prosecution.

We keep getting queries from CDSCO. What is the one thing we should fix?

Make every document match your intended use statement. This is the biggest cause of queries. If the statement says the product supports a diagnosis, the clinical evaluation, labels, risk file and instructions must all say the same. Lock the statement first. Share it with every team. Check each document against it before you file.

Can we answer CDSCO's queries a few at a time?

It is better not to. CDSCO expects one complete answer to each round of queries. Partial answers lead to another round, and that can add months. Treat each response like a small filing: a table with each query, your answer, and the document that supports it.

Which document problems cause avoidable delays?

Breaking the Sugam portal's rules on file names, file sizes and required sections. Filings are often sent back before technical review even starts. Common causes are wrongly named files, a declaration missing its signature, or a contents page that does not match the document.

Can we use AI to help with the literature review for a clinical evaluation report?

Yes, for searching, removing duplicates and first screening. But a qualified clinical evaluator must write, assess and sign the report. AI output copied into the report without expert judgement does not meet the standard. Record the evaluator's qualifications, method and declaration.

Can a machine learning model trained on Western data be validated on 50 to 100 Indian patients?

Usually not, for a Class C application. That is too few patients to show how the model performs across the people who will use it. This matters most where Indian patients present differently. The sample size must be justified with statistics. A small bridging study can create a bigger evidence problem than it solves.

Why do drug-device combination products get stuck at classification?

Because the company has not decided the primary mode of action: whether the drug or the device does the main job. This decides who leads the review and which rules apply first. Put the reasoning in the dossier from day one.

We make a herbal oil for joint pain. Our distributor wants to sell it as a medical device. Is that allowed?

Usually not. If the oil works through a drug-like action in the body, it is regulated as a medicine, not a device. Calling it a device to avoid medicine registration is checked during review and can lead to rejection. Which medicine rules apply depends on the product.

We are halfway through a query cycle and struggling. Is it too late to get help?

No. But late help costs time, because a new adviser must first find the gaps. The best time to bring in a regulatory partner is when the dossier is being prepared. The next best is when the first query arrives. If you have had more than two rounds of queries on the same issue, get specialist help now.

These answers are general information, not advice for your product. Rules change. Check the latest guidance, or ask our team about your product.

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Start a conversation

Talk to a regulatory lead.

Tell us about your product and the markets you want to reach. We will suggest a route to approval and tell you what the dossier needs.

Tell us about your product → Or call +91 88671 25414