Our Leadership | MedRegX
Our Team

Our Leadership Team

Meet the regulatory experts, scientists, and industry veterans who lead MedRegX India's consulting practice.

Leadership

Expert Regulatory Professionals

Our team brings together decades of experience across all regulatory domains in India and internationally.

Anaya Sharma

Anaya Sharma

Founder & CEO

MBA, Regulatory Affairs Expert6+ Years

Visionary founder with deep expertise in Indian regulatory affairs. Leads MedRegX India's strategic vision and has successfully guided 500+ projects across healthcare and compliance sectors.

Strategic LeadershipCDSCO RegulationsBusiness Development
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Shivam Sharma

Shivam Sharma

Executive Director

B.Tech, Regulatory Compliance Specialist6+ Years

Executive Director driving operational excellence. Specializes in medical device registration, BIS/ISI certification, and building robust regulatory compliance frameworks for clients.

Medical Device RegulationBIS CertificationQuality Systems
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Aditya Bhati

Aditya Bhati

Operational Head

MBA Operations, ISO Lead Auditor5+ Years

Operations leader ensuring seamless project delivery. Expert in process optimization, quality auditing, and managing end-to-end regulatory consulting workflows.

Process OptimizationClient DeliveryISO Standards
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Deep Joshi

Deep Joshi

Sales Director

MBA Marketing & Sales5+ Years

Sales strategist driving revenue growth and client acquisition. Builds lasting client relationships and identifies new opportunities across pharmaceutical, medical device, and FMCG sectors.

Client RelationsMarket StrategyRevenue Growth
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Mukeshwar Rai

Mukeshwar Rai

Business Development Manager

B.Com, Business Development4+ Years

Dynamic BDM responsible for expanding MedRegX's market presence. Expert in building strategic partnerships and identifying high-value opportunities across regulatory sectors.

Lead GenerationPartnership BuildingMarket Expansion
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Ankit Yadav

Ankit Yadav

Legal Adviser

LLB, Corporate & Regulatory Law6+ Years

Legal expert advising on regulatory law, intellectual property rights, and contract management. Ensures legal compliance across all MedRegX consulting engagements.

Regulatory LawIPRContract Management
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MedRegX regulatory consulting office | MedRegX
CDSCO Approved
Medical Device Registration
ISO 9001:2015
Quality Certified Firm
Pan India
Coverage & Support
98% Success
Application Rate
10+
Years of Regulatory Excellence
Award Winning
Best Regulatory Firm 2023

Meet the Regulatory Experts Leading MedRegX India

A regulatory consulting firm is only as good as the people reading the dossiers, and MedRegX India's leadership team was built deliberately around specialisation rather than generalism. Each practice area — medical devices, pharmaceuticals, environmental compliance, cosmetics, food, and BIS/international certification — is led by someone who has spent years inside that specific regulator's process, not a generalist rotating across sectors.

Why specialist leadership matters

CDSCO, BIS, FSSAI, and CPCB are four different bureaucracies with four different cultures, forms, and unwritten expectations. A consultant who files CDSCO medical device registrations every week develops an instinct for how a Device Master File should read that a generalist simply cannot replicate part-time. That is why our leadership structure mirrors our service lines exactly: a dedicated head for pharmaceutical regulatory affairs, a dedicated head for environmental and EPR compliance, a dedicated lead for BIS and international certifications, and so on.

This matters most when a filing hits a query. A generic response to a CDSCO or BIS objection often triggers a second round of questions; a response drafted by someone who has resolved that exact objection dozens of times before tends to close the query in one round. That difference compounds across hundreds of filings a year, and it is the main reason our applications clear technical review as often as they do on the first attempt.

Depth across every regulated sector

Our medical device and pharmaceutical leads manage CDSCO compliance, drug licensing, and ISO 13485 quality systems for domestic manufacturers and importers alike. Our environmental lead has personally guided well over a hundred manufacturers through EPR registration and pollution-control-board consents on the CPCB portal. Our cosmetic and AYUSH specialist handles import registration, label compliance, and AYUSH manufacturing licences for brands entering India from overseas.

On the certification side, our BIS and international-standards lead runs BIS CRS and FMCS certification projects alongside CE marking support for medical devices bound for the European market — coordinating directly with BIS field inspectors and Notified Bodies rather than working through intermediaries. Our food and nutraceutical lead manages FSSAI Central and State licensing, product approvals, and the FoSCoS portal filings that trip up applicants who attempt them without guidance.

A team that grows with the file, not around it

Every client is assigned a single point of contact from this leadership bench — someone who owns the file from initial classification through to the certificate, and who stays reachable for renewals and amendments after. We do not rotate accounts between junior staff to free up senior time; the person who scoped your engagement is the person who signs off on your submission.

That continuity is deliberate. Regulatory files accumulate context — prior queries, a reviewer's specific preferences, a plant's inspection history — and losing that context between consultants is exactly how avoidable delays creep back in. Keeping ownership with one specialist for the life of the engagement is one of the simplest ways we protect the timeline we quote at the start.

Work directly with the team

If your product needs BIS certification, EPR registration, FSSAI licensing, or CDSCO approval, you will be working with the specialist who owns that practice area, not a generalist reading from a checklist. Talk to our leadership team about your specific product and timeline, and we will match you with the right lead from the first call.

Frequently Asked Questions

Yes — every engagement is led by the specialist for that regulatory domain (medical devices, pharma, environmental, cosmetics, food, or BIS/international), not a generalist account manager.
Yes. The consultant who scopes your engagement stays as your point of contact through submission, query responses, and the certificate — and remains reachable for renewals afterward.
Yes — our BIS and international certifications lead coordinates directly with Notified Bodies and BIS field inspectors for foreign manufacturers seeking Indian market access, including as Authorised Indian Representative.
Individually, our practice leads carry 6 to 12+ years of focused experience in their specific domain, with hundreds of filings each across CDSCO, BIS, FSSAI, and CPCB.
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