About NKB Regovanta
About NKB Regovanta - Global Medical Device Regulatory Consultants
GLOBAL EXPERTISE. STRATEGIC EXECUTION. HEALTHCARE WITHOUT BORDERS.
A global regulatory, quality and market access partner helping organizations navigate complexity and advance healthcare innovation.
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
INDIA
USA
EU
UK
CANADAONE PARTNER. FIVE INDUSTRIES.
MEDICAL DEVICES
Regulatory, quality, scientific and market-access support across the product lifecycle.
IVDs
Regulatory strategy, performance evidence, quality and market readiness for diagnostic technologies.
PHARMACEUTICALS
CDSCO import licensing, foreign manufacturer registration, AIR representation and post-approval compliance.
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.
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.
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.
Founder, Chief Executive Officer
Saurav Gupta
Chief Operating Officer
Daniel M.
Business Development & Market Access
Satish M.
Manager, Human Resources
Swati Mishra
Quality Assurance and Regulatory Affairs
READY TO NAVIGATE YOUR NEXT MARKET?
Regulatory complexity shouldn't slow responsible innovation.
Let's build the pathway together.