Global healthcare expertise across regulatory, quality and market access

About NKB Regovanta

GLOBAL EXPERTISE.
STRATEGIC EXECUTION.
HEALTHCARE WITHOUT BORDERS.

A global regulatory, quality and market access partner helping organizations navigate complexity and advance healthcare innovation.

Global Perspective
Scientific Rigor
Practical Execution
From India to the world

FROM INDIA. TO THE WORLD.

Built on experience. Driven by purpose.

Our journey began in 2018 and in 2026, NKB Regovanta was formally established to bring deep regulatory, scientific and quality expertise together under one global vision.

Today, we support Medical Devices, IVDs and Cosmetics across India and international markets.

India is our foundation.
The world is our horizon.

2018

Experience begins

2019–2025

Expanding expertise

2026

NKB Regovanta

Global market access network from India

FROM LOCAL EXPERTISE
TO GLOBAL MARKET ACCESS

Healthcare innovation is global.
Regulatory pathways are not.

We help organizations build clear, compliant and market-ready strategies across major and emerging markets.

ONE PARTNER. FOUR INDUSTRIES.

Medical Devices

MEDICAL DEVICES

Regulatory, quality, scientific and market-access support across the product lifecycle.

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IVDs

IVDs

Regulatory strategy, performance evidence, quality and market readiness for diagnostic technologies.

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Pharmaceuticals & Drugs

PHARMACEUTICALS

CDSCO import licensing, foreign manufacturer registration, AIR representation and post-approval compliance.

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Cosmetics

COSMETICS

Product safety, regulatory compliance, quality and market requirements.

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Different products. Different pathways. One commitment to safety, quality and integrity.

REGULATORY & SCIENTIFIC EXPERTISE

REGULATORY & MARKET ACCESS

Regulatory strategy, classification, submissions and market-entry pathways.

QUALITY & COMPLIANCE

QMS strategy, ISO 13485, MDSAP, audits and lifecycle compliance.

CLINICAL & SCIENTIFIC

Clinical, preclinical, biological safety and evidence strategy.

TECHNICAL & STRATEGIC

Technical documentation, risk management and product-development strategy.

ISO 13485|MDSAP|FDA|EU MDR|EU IVDR|SaMD|GLOBAL MARKET ACCESS

WHY NKB REGOVANTA

Multi-market regulatory expertise across Medical Devices, IVDs, Pharmaceuticals and Cosmetics.

MARKET-ENTRY CAPABILITY

Local regulatory representation, licensing and market-entry support.

END-TO-END LIFECYCLE SUPPORT

From classification and registration through post-market compliance.

SENIOR REGULATORY EXPERTISE

Experienced regulatory professionals managing complex submissions and authority interactions.

Beyond compliance. Built for market access.

BUILT FOR INNOVATORS.

From early-stage startups to established manufacturers, we adapt to your complexity, maturity and ambitions.

Startups| Scale-ups| Established Manufacturers

BEYOND COMPLIANCE.

A medical device can improve a patient's life.

An IVD can contribute to a diagnosis.

A cosmetic product can enhance everyday wellbeing.

Behind every product is a person.

That is why compliance is not the destination.
It is the foundation for trust.

THE JOURNEY CONTINUES

2018

FOUNDATION

Experience begins.

2019–2025

EXPANDING EXPERTISE

Regulatory. Quality. Clinical. Scientific. Global market access.

2026

NKB REGOVANTA

One organization.
One vision.
One global perspective.

FUTURE

FROM INDIA. FOR THE WORLD.

Global growth.
Responsible innovation.
Meaningful impact.

Leadership

Meet Our Key Leaders

Experienced professionals committed to advancing regulatory excellence and healthcare innovation.

Usha S.

Usha S.

Founder, Chief Executive Officer

Executive LeadershipStrategic DirectionOperations
Saurav Gupta

Saurav Gupta

Chief Operating Officer

Executive LeadershipOperationsProcess Management
Daniel M.

Daniel M.

Business Development & Market Access

Business DevelopmentMarket AccessClient Relations
Satish M.

Satish M.

Manager, Human Resources

Human ResourcesTalent ManagementOrganizational Development
Ritu Dixit

Ritu Dixit

Quality Assurance and Regulatory Affairs

Quality AssuranceRegulatory AffairsCompliance

READY TO NAVIGATE YOUR NEXT MARKET?

Regulatory complexity shouldn't slow responsible innovation.
Let's build the pathway together.