Regulatory. Quality. Manufacturing. Market Access.

Global Medical Device Regulatory & Market Access Consulting

Medical Devices | IVDs | Pharmaceuticals | Cosmetics | Manufacturing

From First Idea to Global Market Access.

NKB Regovanta is a premier global medical device consultant and regulatory affairs consultancy. We provide end-to-end regulatory strategy, testing coordination, technical documentation, and market access for Medical Devices, IVDs, Pharmaceuticals, and Cosmetics across India (CDSCO), the United States (USFDA 510 k / 510k), and international markets.

As a trusted medical device consultancy, our senior consultants support manufacturers with USFDA 510(k) clearances, eSTAR submissions, CDSCO manufacturing & import licensing (MD-14/15, MD-3 to MD-9), EU MDR/IVDR CE marking, and ISO 13485 QMS certification.

Global regulatory compliance for medical devices

2018

Experience Since

Regulatory & Quality
Experience

151+

Completed

Regulatory & Quality
Projects

21+

Supported

Global
Clients

15+

Supported

International
Countries

4

Focus Areas

Core
Industries

Global

India Based

Connected Network
of Experts

OUR EXPERTISE

End-to-End Regulatory, Quality, Manufacturing & Market Access Support

Integrated compliance, quality management, manufacturing solutions, and commercial market-entry across global healthcare verticals.

Medical Devices & IVDs

  • โ€ขRegulatory Strategy
  • โ€ขProduct Classification
  • โ€ขRegistration & Licensing
  • โ€ขTechnical Documentation
  • โ€ขUS FDA 510(k)
  • โ€ขEU MDR / IVDR
  • โ€ขCDSCO, TGA, UAE, APAC Registrations

Pharmaceuticals & Drugs

  • โ€ขCDSCO Drug Import Licensing
  • โ€ขRegistration Certificate (Form 41)
  • โ€ขImport Licence (Form 10 / 10-A)
  • โ€ขForeign Manufacturer Registration
  • โ€ขIndian Authorized Agent (AIR)
  • โ€ขWholesale & Distribution Licensing
  • โ€ขPost-Approval Variations & Lifecycle

Quality Systems

  • โ€ขISO 13485 Implementation
  • โ€ขMDSAP Support
  • โ€ขQMS Development
  • โ€ขInternal Audits
  • โ€ขCAPA Management
  • โ€ขSupplier Quality
  • โ€ขCertification & Audit Readiness

Product & Market Access

  • โ€ขDesign Controls
  • โ€ขISO 14971 Risk Management
  • โ€ขClinical & Performance Documentation
  • โ€ขTesting Strategy
  • โ€ขMarket Entry Strategy
  • โ€ขPost-Market Compliance
  • โ€ขVigilance & Reporting

Cosmetics

  • โ€ขRegulatory Assessment
  • โ€ขProduct Compliance
  • โ€ขRegistration / Notification
  • โ€ขLabeling & Claims Review
  • โ€ขDocumentation Support
  • โ€ขMarket Entry Strategy

OUR INTEGRATED CAPABILITY

Integrated Manufacturing & Facility Solutions

Integrated equipment, manufacturing, cleanroom and compliance solutions for pharmaceutical, medical-device and healthcare organizations.

Pharmaceutical Equipment

Pharmaceutical Equipment

  • โ€ขDe-dusters, Tray Dryers
  • โ€ขOctagonal, V-Type Blenders
  • โ€ขMass Mixers, Pass Boxes
  • โ€ขPowder Filling Machines
  • โ€ขMaterial Handling Solutions
Cleanroom & Facility Solutions

Cleanroom & Facility Solutions

  • โ€ขSS Tables, Workstations
  • โ€ขTrolleys, Lockers, Containers
  • โ€ขWash Basins, Wall Guards
  • โ€ขCross-over Benches
  • โ€ขElectrical Panels, Ladders
Healthcare & Surgical Products

Healthcare & Surgical Products

  • โ€ขSterile Masks, Surgical Aprons
  • โ€ขBouffant Caps, Shoe Covers
  • โ€ขSterile Hand Gloves
  • โ€ขOther Healthcare Consumables
Technical & Compliance Support

Technical & Compliance Support

  • โ€ขTechnical Documentation
  • โ€ขProduct Specifications
  • โ€ขQuality & Compliance Support
  • โ€ขCustomer-specific Solutions

OUR END-TO-END APPROACH

1. UNDERSTAND

We understand your technical, operational and commercial requirements.

2. DEFINE

We define the right solution, specifications and execution plan.

3. ENGINEER & MANUFACTURE

We engineer and manufacture through established capabilities.

4. QUALITY & DOCUMENTATION

We ensure quality, testing, documentation and compliance.

5. DELIVER

We coordinate logistics and ensure on-time delivery.

6. SUPPORT

We provide ongoing support for your business needs.

Our Clients & Partners

Trusted by Leading Organizations

Powering global regulatory approvals, CDSCO & US FDA licensing, quality systems (ISO 13485 / MDSAP), and precision manufacturing solutions for premier institutions worldwide.

Roche

Roche

F. Hoffmann-La Roche AG

Diagnostics & Pharma
Abbott

Abbott

Abbott Laboratories

Medical Devices & IVDs
Ipca

Ipca

Ipca Laboratories Ltd.

Pharmaceuticals
Cipla

Cipla

Cipla Global Healthcare

Pharmaceuticals
Felix

Felix

Felix Generics Pvt Ltd

Generics
PAR

PAR

PAR Pharmaceutical

Global Pharma
AstraZeneca

AstraZeneca

AstraZeneca International

Biopharma
ACG

ACG

ACG Worldwide

Machinery & Capsules
PV PROCON VENTURES

PV PROCON VENTURES

Procon Ventures

Engineering
Dr.Reddy's

Dr.Reddy's

Dr. Reddy's Laboratories

Pharmaceuticals
เค‡เคธเคฐเฅ‹ isro

เค‡เคธเคฐเฅ‹ isro

Indian Space Research Organisation

Aerospace & Tech
NOVARTIS

NOVARTIS

Novartis Healthcare

Global Healthcare
UNICHEM LABORATORIES LTD.

UNICHEM LABORATORIES LTD.

Unichem Laboratories

Formulations
Encube

Encube

Encube Ethicals

Topicals & Pharma
Knovea

Knovea

Knovea Pharmaceuticals

Healthcare
SYMBIOTEC PHARMALAB (P) LIMITED

SYMBIOTEC PHARMALAB (P) LIMITED

Symbiotec Pharmalab

Steroid APIs
Pfizer

Pfizer

Pfizer Pharmaceuticals

Global Pharma
เคญเคพ. เคชเฅเคฐ. เคธเค‚. เค‡เคจเฅเคฆเฅŒเคฐ IIM INDORE

เคญเคพ. เคชเฅเคฐ. เคธเค‚. เค‡เคจเฅเคฆเฅŒเคฐ IIM INDORE

เคธเคฟเคฆเฅเคงเคฟเคฐเฅเคฎเฅ‚เคฒเค‚ เคชเฅเคฐเคฌเคจเฅเคงเคจเคฎเฅ

Institutions
Kusum Healthcare

Kusum Healthcare

Kusum Healthcare Pvt. Ltd.

Pharmaceuticals
Growing alongside leaders in healthcare, diagnostics and life sciences.
Client Testimonials & Endorsements

What Industry Leaders Say About Us

Direct feedback from pharmaceutical executives, enterprise life-science leaders, and medical device innovators who trust NKB Regovanta for regulatory clearance, QMS readiness, and market access.

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Pharmaceutical Regulatory Strategy
Client Testimonial
โ€œWhat stands out about NKB Regovanta is their structured and solution-oriented approach to regulatory challenges. They bring clarity to complex requirements, maintain strong attention to compliance detail, and work with a high level of ownership and responsiveness throughout the engagement.โ€
โœ“ Structured Approachโœ“ Solution-Orientedโœ“ High Ownership & Detail
Kusum Healthcare Pvt Ltd

N. CHANDRA SHEKHAR

Executive Vice President, Kusum Healthcare Pvt Ltd

Global Pharmaceuticals ยท India & International Markets
Medical Devices & EU MDR
Client Testimonial
โ€œNKB Regovanta has demonstrated strong regulatory and quality expertise, combined with a highly practical and responsive working style. Their structured approach to gap assessment, documentation, compliance readiness and regulatory strategy has helped us manage complex requirements with greater clarity and confidence.โ€
โœ“ Regulatory & Quality Expertiseโœ“ Gap Assessment & QMSโœ“ Practical & Responsive
RR

Rolandas Ragaisis

Lithuania / EU

Managing Director, UAB Vitacon LT

Ultrasound & Medical Devices ยท Lithuania, European Union
Medical Devices & IVD Compliance
Client Testimonial
โ€œNKB Regovanta has a good understanding of the regulatory requirements applicable to medical devices and IVD products. I have appreciated their practical approach, attention to detail, and the way they keep the process clear and well coordinated. They are a dependable team for regulatory and compliance support.โ€
โœ“ Medical Device & IVDโœ“ Process Clarityโœ“ Dependable Support
TCS

Prashant Singh

Lead Consultant, TCS

Life Sciences & Digital Health ยท India & Global
EU IVDR Compliance
Client Testimonial
โ€œMy experience with NKB Regovanta has been positive, particularly in the area of EU IVDR requirements. Their team has been responsive and clear in explaining the regulatory expectations and documentation requirements. They bring a practical approach to IVDR projects and are easy to work with.โ€
โœ“ EU IVDR Requirementsโœ“ Clear Documentationโœ“ Practical & Responsive
Genpact

Mohd Farrukh Khan

Senior Manager, Genpact

Healthcare & Life Sciences Regulatory ยท Global Operations
Medical Device Strategy
Client Testimonial
โ€œI worked with NKB Regovanta in connection with regulatory consultancy support for medical device projects. The team was approachable and willing to work through the details with the project team. Their inputs were useful in understanding the regulatory aspects and planning the next steps.โ€
โœ“ Approachable Teamโœ“ Actionable Guidanceโœ“ Strategic Project Planning
Wipro

Parag Giri

Senior Project Manager, Wipro

Medical Device Engineering ยท India & Global
Experience Since 2018 ยท 151+ Projects Completed

Ready to Experience the Same High Standard of Regulatory Support?

Whether you need CDSCO registration in India, US FDA 510(k) clearances, EU MDR/IVDR compliance, or integrated cleanroom manufacturing solutions, our specialists ensure structured, responsive execution.