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Business Surgeons Consulting

Delivering Quality with Speed in Regulated Markets

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.

Business Success
100%
What We Do

Our Services

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Medical Devices

Launch and scale your medical devices in India, the US, and Europe with end‑to‑end regulatory execution—not guesswork. ....

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Cosmetics

Bring your cosmetic brands to India with zero regulatory guesswork. We help you unlock the CDSCO market with......

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Pharmaceutical

Bring your formulations from lab bench to global markets with a single, integrated pharma regulatory partner.....

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Common

Build compliance foundations that work across every industry you operate in. Our common services....

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Mission & Vision

we align regulatory strategy, documentation and execution to deliver quality with speed.

To 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.

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Years Of Experience
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Scalable Solutions

End to end fiber optic cable nnectivity for stable

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Automation Features

End to end fiber optic cable nnectivity for stable

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24/7 Support

End to end fiber optic cable nnectivity for stable

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HOW WE WORK

Connect, Collaborate, & Create
Limitless Opportunities.

01

Requirement Analysis

We understand your regulatory needs.

02

Regulatory Strategy

We plan the right approval path.

03

Documentation

We prepare compliant documents.

04

Submission & Approval

We prepare compliant documents.

Embrace Innovation, Adapt Quickly, and Lead with Confidence. Consult Now

Industries Served

BSC’s experience spans multiple high‑technology and regulated sectors:

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Business Surgeons Consulting

Key Differentiators

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.

BRANDS TRUST US
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“Business Surgeons Consulting guided us through a very challenging CDSCO registration and MD‑42 licence with exceptional clarity and speed. Their deep understanding of regulatory requirements, proactive problem‑solving and precise portal execution helped us secure approvals smoothly and keep our operations uninterrupted,” shared the Managing Director, Össur India Pvt. Ltd.

“We were impressed by their professionalism, responsiveness and commitment at every stage of the project. Based on our experience, Össur India is pleased to recommend Business Surgeons Consulting to any organisation seeking reliable, knowledgeable support in regulatory compliance.”

“Business Surgeons Consulting has been an outstanding partner to JD Healthcare, supporting us across SUGAM profile updates, test licences, import and distribution/wholesale licences, and plant set‑up–related regulatory requirements. Their team combines deep CDSCO expertise with pragmatic problem‑solving and a very professional way of working, which helped us secure clearances in several complex and sensitive cases where others had struggled.”

“They consistently exceed expectations in responsiveness, ownership and quality of advice. As Managing Director, JD Healthcare, I confidently recommend Business Surgeons Consulting as a dependable, commercially aware partner for regulatory, licensing, compliance and related advisory assignments, and we look forward to continuing our association.”

“Business Surgeons Consulting supported **Drake Medtech** on one of our most complex projects—a CDSCO MD‑15 import licence for a high‑speed drill portfolio with more than 500 individual parts. They completely restructured our product master, aligned classifications and descriptions with CDSCO expectations, and drove the application to approval in a remarkably short timeframe, without disrupting our supply to hospitals.”

“As **Regulatory & Operations Lead, Drake Medtech**, I was impressed by their in‑depth domain understanding, meticulous data handling and sharp liaisoning with CDSCO reviewers. This assignment clearly demonstrated BSC’s ability to untangle highly technical portfolios and convert them into smooth, successful import licences, and we look forward to engaging them on future registrations.”

Ossur India Private Limited

JD Healthcare

Drake Medtech

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Leadership

Praveen Kumar – Founder, Business Surgeons Consulting

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......

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