Medical device regulatory consulting between India, the United States, the European Union and Canada — from a team of doctors who became regulatory professionals.
Markets we work in
Focused help at the points that decide whether your device reaches the market — and how smoothly it gets there.
Before you commit time and budget, we map the route: how your device is likely to be classified, which pathway fits, what evidence regulators will expect, and which market makes sense first.
A second set of expert eyes before a regulator sees your file. We review your technical file or dossier against the requirements of the market you’re entering, and tell you plainly what’s missing, unclear or at risk.
Approval is where a device’s obligations begin. We help you assess complaints, report what needs reporting on time in each market, and keep your post-market records ready for inspection.
Foreign manufacturers can’t apply to CDSCO directly. We can act as your Indian Authorized Agent — CDSCO’s point of contact for your device — so your licence isn’t tied to a distributor.
We help compile and prepare submissions and licence applications, so what you file is complete and consistent.
When a regulator comes back with questions, we help you respond clearly, completely and on time.
For global manufacturers
Maybe you’ve promised a doctor in India that you’d bring your device, because their patients need it — and you still haven’t found a partner who can make it happen. Reach out. We’ll work together to meet your need, and your patients’.
For Indian manufacturers
Not knowing where to start — or not finding a consultant who truly understands devices — shouldn’t keep your product at home. We’ll help you enter every market your product deserves, and build the strategy to get there.
At many consultancies, a device question lands on the same desk as a stack of drug submissions. We don’t have a drug desk. Our time goes into medical devices — so your questions are answered by people who know devices.
Our team trained as doctors before moving into regulatory affairs, and built its experience in the United States on US and global device submissions. We know what a device means to a patient — and what it takes to get it approved.
And you won’t have to chase us. We keep you informed before you need to ask, and we tell you plainly where things stand.
A patient-first approach, on every project.
Before we explain your product to a regulator, we invest the time to understand it deeply — and look for ways to add value to it along the way.
We build a strategic plan for your submission, designed to move it past hurdles as efficiently as possible.
We present your device to the authorities clearly and completely, and keep you updated at every stage.
We care about medical devices — and we strive to do right, for innovators and for patients.
So you can stay focused on innovation, while we handle the regulatory work.
Share where your device is today and where it needs to go. We’ll reply with clear next steps.