Business Surgeons Consulting (BSC) brings over two decades of regulatory and engineering expertise from global leaders, specializing in medical devices, pharma and cosmetics compliance across India, the US, EU and other highly regulated geographies.
We streamline regulatory approvals, certifications and quality systems so you can focus on innovation and growth while we ensure seamless market access and regulatory success.
Launch and scale your medical devices in India, the US, and Europe with end‑to‑end regulatory execution—not guesswork. ....
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Bring your formulations from lab bench to global markets with a single, integrated pharma regulatory partner.....
Read MoreTo become India’s most respected regulatory consultancy, setting global benchmarks in compliance excellence for medical devices, pharma and cosmetics.
To prioritise client needs by delivering cost‑effective, timely regulatory and quality solutions that exceed expectations through deep technical expertise and disciplined execution.
Excellence – We strive for excellence in everything we do, delivering high‑quality solutions that consistently exceed client expectations.
Integrity – We conduct business with uncompromising integrity, honesty and transparency, ensuring full trust and accountability in every engagement.
Collaboration – We work closely with our clients, fostering collaboration, knowledge‑sharing and long‑term partnerships.
End to end fiber optic cable nnectivity for stable
End to end fiber optic cable nnectivity for stable
End to end fiber optic cable nnectivity for stable
We understand your regulatory needs.
We plan the right approval path.
We prepare compliant documents.
We prepare compliant documents.
Full‑spectrum support across US FDA, CDSCO (MD‑1 to MD‑40), EU MDR, pharma and cosmetics licensing, clinical trials and import/export NOCs, with practical insights from launching Class II/III devices globally.
Starting from plant set‑up, layout design and QMS establishment through to technical file creation, testing, device registration and post‑market obligations.
Strategies and documentation customised for India, US, EU and other markets, including streamlined clearances, permissions and NABL‑approved testing.
Proven experience leading large offshore delivery centres and complex project portfolios, aligning R&D, operations, sales, marketing, demand planning, sourcing and manufacturing.

Praveen Kumar is the Founder and Managing Partner of Business Surgeons Consulting, a specialist firm dedicated to navigating complex medical device, pharma and cosmetics regulations in India and globally......