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.

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
- โขRegulatory Strategy
- โขProduct Classification
- โขRegistration & Licensing
- โขTechnical Documentation
- โขUS FDA 510(k)
- โขEU MDR / IVDR
- โขCDSCO, TGA, UAE, APAC Registrations
Pharmaceuticals & Drugs
- โขCDSCO Drug Import Licensing
- โขRegistration Certificate (Form 41)
- โขImport Licence (Form 10 / 10-A)
- โขForeign Manufacturer Registration
- โขIndian Authorized Agent (AIR)
- โขWholesale & Distribution Licensing
- โขPost-Approval Variations & Lifecycle
Quality Systems
- โขISO 13485 Implementation
- โขMDSAP Support
- โขQMS Development
- โขInternal Audits
- โขCAPA Management
- โขSupplier Quality
- โขCertification & Audit Readiness
Product & Market Access
- โขDesign Controls
- โขISO 14971 Risk Management
- โขClinical & Performance Documentation
- โขTesting Strategy
- โขMarket Entry Strategy
- โขPost-Market Compliance
- โขVigilance & Reporting
Cosmetics
- โขRegulatory Assessment
- โขProduct Compliance
- โขRegistration / Notification
- โขLabeling & Claims Review
- โขDocumentation Support
- โขMarket 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
- โขDe-dusters, Tray Dryers
- โขOctagonal, V-Type Blenders
- โขMass Mixers, Pass Boxes
- โขPowder Filling Machines
- โขMaterial Handling Solutions

Cleanroom & Facility Solutions
- โขSS Tables, Workstations
- โขTrolleys, Lockers, Containers
- โขWash Basins, Wall Guards
- โขCross-over Benches
- โขElectrical Panels, Ladders

Healthcare & Surgical Products
- โขSterile Masks, Surgical Aprons
- โขBouffant Caps, Shoe Covers
- โขSterile Hand Gloves
- โขOther Healthcare Consumables

Technical & Compliance Support
- โขTechnical Documentation
- โขProduct Specifications
- โขQuality & Compliance Support
- โขCustomer-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.
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
F. Hoffmann-La Roche AG
Diagnostics & Pharma
Abbott
Abbott Laboratories
Medical Devices & IVDs
Ipca
Ipca Laboratories Ltd.
Pharmaceuticals
Cipla
Cipla Global Healthcare
Pharmaceuticals
Felix
Felix Generics Pvt Ltd
Generics
PAR
PAR Pharmaceutical
Global Pharma
AstraZeneca
AstraZeneca International
Biopharma
ACG
ACG Worldwide
Machinery & Capsules
PV PROCON VENTURES
Procon Ventures
Engineering
Dr.Reddy's
Dr. Reddy's Laboratories
Pharmaceuticals
เคเคธเคฐเฅ isro
Indian Space Research Organisation
Aerospace & Tech
NOVARTIS
Novartis Healthcare
Global Healthcare
UNICHEM LABORATORIES LTD.
Unichem Laboratories
Formulations
Encube
Encube Ethicals
Topicals & Pharma
Knovea
Knovea Pharmaceuticals
Healthcare
SYMBIOTEC PHARMALAB (P) LIMITED
Symbiotec Pharmalab
Steroid APIs
Pfizer
Pfizer Pharmaceuticals
Global Pharma
เคญเคพ. เคชเฅเคฐ. เคธเค. เคเคจเฅเคฆเฅเคฐ IIM INDORE
เคธเคฟเคฆเฅเคงเคฟเคฐเฅเคฎเฅเคฒเค เคชเฅเคฐเคฌเคจเฅเคงเคจเคฎเฅ
Institutions
Kusum Healthcare
Kusum Healthcare Pvt. Ltd.
PharmaceuticalsWhat 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.
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.












