IQZYME MEDTECH PVT LTD

What IQZYME MEDTECH PVT LTD does

IQZYME MEDTECH PVT LTD is an India-based, founder-led B2B regulatory consulting firm specializing in compliance for medical devices and in vitro diagnostics (IVDs). The company serves manufacturers and exporters navigating three parallel regulatory regimes — India's Central Drugs Standard Control Organization (CDSCO), the European Union's MDR 2017/745 and IVDR 2017/746 (CE Marking), and the US FDA — alongside multi-ISO quality management system implementation (ISO 13485, 9001, 15189, 17025, 22000, 45000). Headquarters are in Cochin, Kerala, with four additional regional offices in Mumbai, Bengaluru, Coimbatore, and New Delhi, and the firm operates with approximately 20 employees under the direction of Mr. Sinto Poulose (Founder Director, 17+ years' expertise), Mrs. Selma S (Director, 19+ years), and Dr. Chandranand (Director, 25 years at NIB).

The company's core offerings are organized into six consulting lines: (1) CDSCO licensing (manufacturing, import, test, loan, wholesale, and retail licenses under the Indian Medical Device Rules 2017); (2) EU and US international regulatory services, including technical file preparation, clinical evaluation reports, SaMD/SiMD software validation, European Authorized Representative services, US FDA 510(k) premarket notifications, UDI listings, and MDSAP audit preparation; (3) Quality Management System consultation across multiple ISO standards; (4) Turnkey project services for medical device facility design, clean-room design and validation, and HVAC system design; (5) Intellectual property services covering patents, trademarks, design patents, copyrights, and technology transfer; and (6) adjacent statutory registration services including BIS certification, GeM portal registration, FSSAI registration, EPR / Pollution Control Board consents, Import Export Code (IEC), UDYAM, Factories & Boilers permits, Legal Metrology, and K-Smart registration. The service portfolio has been deliberately widened beyond the original medical-device/IVD core into cosmetics, food, and consumer-goods regulatory verticals.

Revenue is generated through project-based professional services fees for consulting engagements, billed either as fixed-fee/milestone-based turnkey projects or as engagement-specific advisory retainers; pricing is quote-based, varies by jurisdiction, complexity, and scope, and is not publicly disclosed. The go-to-market model is direct enterprise field sales supplemented by participation in international trade exhibitions (Medica 2025 in Germany), a quarterly newsletter (IQZYME INSIGHTS), detailed website content covering CDSCO guidelines and ISO standards, and an online enquiry/quote-request form. The firm reports no institutional investors, no parent company, no subsidiaries, no acquisitions, no patents or trademarks filed, and no named customer logos in the available data.

Name

IQZYME MEDTECH PVT LTD

Legal name

IQZYME MEDTECH PVT. LTD.

Website

https://iqzyme.com

Company type

Private

Operating status

Operating

Headcount range

11–50 employees

Short description

IQZYME MEDTECH PVT LTD is an India-based regulatory consulting firm that guides medical device and IVD manufacturers through CDSCO (India), EU MDR/IVDR CE Marking, US FDA, and ISO QMS compliance, with turnkey facility, clean room, IP, and statutory registration services from five Indian offices.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

NAICS

Other Scientific and Technical Consulting Services (54169)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA)

akta.pro secondary industry

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

Keywords

• Regulatory consulting services
• Medical device compliance
• In vitro diagnostics
• CE marking consulting
• Quality management systems

Headquarters

HQ city

Cochin (Kochi)

HQ country

India

HQ region

Asia

Offices5 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Infrastructure, Technology or R&D

Revenue model

1. Regulatory Consulting and Advisory Services: Professional services fees charged for regulatory consulting engagements covering CDSCO licensing, EU MDR/IVDR, US FDA registration, QMS implementation, and related regulatory affairs. Revenue is project-based and engagement-specific, varying by scope, complexity, and client requirements.
2. Turnkey Project Consultation: Comprehensive consulting engagements for setting up medical device and IVD manufacturing facilities, including clean room design, HVAC design, and validation services, billed as fixed-fee or milestone-based project engagements.
3. Training and Certification Support: Training programs and certification support services for ISO standards, regulatory compliance, and internal auditor training (e.g., ISO 13485, ISO 15189), typically offered as fee-for-service workshops or advisory retainers.
4. Statutory and Compliance Services: Services for obtaining various statutory registrations and certifications including BIS certification, GeM portal registration, EPR registration, IEC code, FSSAI registration, UDYAM registration, Factories and Boilers permits, Legal Metrology certificates, and K-Smart registration, charged on a per-service basis.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

IQZYME MEDTECH PVT LTD is a regulatory consulting firm providing 360-degree services for medical device and IVD manufacturers, including CDSCO licensing, EU MDR/IVDR CE Marking, US FDA registration, ISO QMS implementation, turnkey facility design and clean room validation, and intellectual property services. The company serves domestic and export-oriented manufacturers across India, the European Union and the United States through direct consulting engagements delivered from five Indian offices.

Product overview

IQZYME MEDTECH PVT LTD is a regulatory consulting company specializing in comprehensive compliance services for the medical device, in vitro diagnostics (IVD), pharmaceutical, cosmetics, and food industries in India. The company operates as a multi-service platform offering regulatory consulting across multiple jurisdictions including CDSCO (India), US FDA, EU MDR/IVDR (CE Marking), and various ISO standards. Core service clusters include: (1) Regulatory Licensing Services encompassing CDSCO licensing, manufacturing licenses, import/export licenses, and various statutory registrations (BIS, FSSAI, IEC, GeM, UDYAM); (2) International Regulatory Services including CE Marking under EU MDR/IVDR and US FDA registration; (3) Quality Management System consulting for ISO 13485, ISO 9001, and related standards; (4) Turnkey Project Services for medical device facility design, clean room consultation, HVAC systems, and validation; (5) Intellectual Property Services covering patents, trademarks, copyrights, and technology transfer; and (6) Business Support Services including entrepreneurship facilitation, company formation, and pollution control compliance. The portfolio is structured as standalone consulting service lines rather than an integrated software platform, with specialized offerings for different regulatory pathways and industry segments.

Differentiator

Problem solved

Functional benefit

Products and services

• CDSCO Medical Device/IVD Consulting Services Regulatory consulting for obtaining manufacturing licenses, import licenses, test licenses, loan licenses, and wholesale/retail licenses for medical devices and in vitro diagnostics under India's Central Drugs Standard Control Organization framework.
• Medical Device/IVD Turnkey Projects End-to-end consultation for setting up manufacturing facilities including facility design, clean room consultation, HVAC design, and validation services following CDSCO guidelines and ISO standards.
• Medical Device CE Marking Services Comprehensive CE Marking consultation under EU MDR 2017/745 and EU IVDR 2017/746, including technical file preparation, clinical evaluation reports, software validation (SaMD/SiMD), and European Authorized Representative services.
• US FDA Registration Services Consulting for US FDA establishment registration, 510(k) premarket notification, Device Master Files, Unique Device Identification (UDI) listing, and MDSAP audit preparation.
• Quality Management System (QMS) Consultation Implementation and certification support for ISO 13485, ISO 9001, ISO 45000, ISO 22000, and NABL consultation for ISO 15189/ISO 17025 compliance.
• Patents, Trademarks & Copyrights (IPR Services) Intellectual property services including patent searching, drafting, and prosecution; trademark registration and enforcement; and copyright protection for software, research papers, and marketing materials.
• Cosmetics Licensing and Registration Consultation for cosmetics registration under CDSCO, ISO 22716 GMP compliance, and regulatory submissions for both domestic manufacturing licenses and import registrations.
• BIS Certificate Registration Assistance with Bureau of Indian Standards certification including ISI Mark, FMCS (Foreign Manufacturer Certification Scheme), CRS (Compulsory Registration Scheme), and ECO Mark Scheme.
• GeM Portal Registration Services Government e-Marketplace registration consulting to help businesses participate in government procurement opportunities in India.
• Pollution Control Board Services Extended Producer Responsibility (EPR) registration and Consent to Establish/Operate services for environmental compliance.
• Entrepreneurship Facilitation Center Comprehensive startup support including startup assistance, technology sourcing, technology transfer, company formation, design patents, CDSCO licensing, and detailed project reports (DPR).
• Other Statutory Services Additional regulatory services including Factories and Boilers Permits, Import Export Code (IEC) Registration, Legal Metrology (LMPC) Certificate, FSSAI Registration, UDYAM Registration, and K-Smart Registration.
• Technology Transfer (TOT) Facilitation of technology transfer from research to commercial production, including feasibility analysis, process optimization, scale-up support, and regulatory compliance documentation.
• CDSCO Licensing End-to-end CDSCO licensing support including regulatory strategy development, pre-submission consultation, dossier compilation, clinical evaluation, and post-market surveillance.
• Detailed Project Reports (DPR) Comprehensive project documentation including feasibility analysis, technical specifications, financial projections, market assessment, and regulatory compliance frameworks.
• FSSAI Registration Food Safety and Standards Authority of India registration for businesses handling, processing, or distributing food products, ensuring compliance with food safety regulations.
• UDYAM Registration MSME certification from the Ministry of Micro, Small, and Medium Enterprises to facilitate access to government benefits, subsidies, and support schemes.
• Import Export Code (IEC) Registration Assistance with obtaining IEC from DGFT for businesses engaged in international trade of goods and services.
• K-Smart Registration Kerala e-governance initiative support for obtaining building permissions for medical device manufacturing and importing industries.
• Legal Metrology (LMPC) Certificate Legal Metrology Packaged Commodities registration ensuring compliance with labeling and measurement accuracy standards for pre-packaged goods.
• Factories and Boilers Permits Regulatory approvals for manufacturing facility operations ensuring compliance with safety, health, and environmental standards.
• Design Patents Legal protection services for unique visual characteristics of medical devices and diagnostic products, including patentability assessment, application preparation, and international protection via Hague Agreement.
• Medical Device Manufacturing License Registration Expert services for obtaining CDSCO manufacturing license in India, covering QMS implementation, risk analysis, device testing guidance, clinical evaluations, and device classification support.

Quantifiable outcome

• 100% compliance guidance for regulatory clearances and quality standards
• +1 more outcomes

Segments5 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Scale indicators4 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Parexel International: Global CRO with a sizable regulatory consulting practice covering medical device and pharma submissions in major markets. Comparable to IQzyme's FDA and EU regulatory submission work but oriented to multinational pharma/medtech sponsors rather than Indian SMEs.
• Boston Consulting Group (BCG) / McKinsey (Healthcare Regulatory): Top-tier global strategy consultancies with healthcare regulatory and market entry practices advising medical device and IVD manufacturers. Tangentially comparable for large multinational regulatory transformation mandates, but not a typical competitor for IQzyme's SME client base.
• Navigant Consulting / Guidehouse (MedTech Regulatory): Large international consultancy with a life sciences regulatory and quality practice advising medical device and biopharma clients. Overlaps with IQzyme in EU MDR/IVDR strategy, FDA pathway selection, and QMS implementation, but serves enterprise-scale manufacturers.
• UL Solutions: Global testing, inspection, and certification giant offering medical device regulatory and quality services including MDSAP audits, ISO 13485 certification, and EU/US regulatory support. Comparable to IQzyme's QMS and international regulatory lines but at vastly greater scale and geographic reach.
• TÜV SÜD: Global notified body and testing organization providing CE Marking, ISO 13485 certification, and MDSAP audits for medical device manufacturers. Overlaps with IQzyme's EU MDR/IVDR and QMS consulting offerings but with substantial in-house lab and certification infrastructure.

Direct peers

• Freyr Solutions: India-headquartered global regulatory affairs and compliance services firm for life sciences, medical devices, and IVDs. Directly comparable to IQzyme in cross-jurisdictional regulatory consulting (FDA, EMA, MHRA, CDSCO), with a much larger global footprint and headcount.
• CliniExperts: India-based regulatory affairs and clinical research services firm covering CDSCO, US FDA, and EU compliance for medical devices, IVDs, and pharma. Closely comparable in target client (Indian manufacturers) and service scope, including licensing and turnkey support.
• I3CGLOBAL: Indian regulatory and pharmacovigilance consulting firm offering medical device, pharma, and biologics regulatory services across US, EU, and emerging markets. Comparable to IQzyme in providing CE Marking, FDA, and CDSCO support, with overlapping target client base of Indian manufacturers.
• SQA Services: US-based quality and regulatory consulting firm for medical devices and IVDs offering FDA 510(k), CE Marking, ISO 13485, and MDSAP services. Directly comparable in service line mix and regulatory framework coverage, with comparable mid-market positioning.
• Kaizen Life Sciences: India-based regulatory and quality consulting firm serving pharmaceutical, medical device, and IVD manufacturers. Comparable to IQzyme in CDSCO licensing, ISO 13485 QMS, and EU/US regulatory support for Indian exporters.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/iqzyme-medtech-pvt-ltd

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about IQZYME MEDTECH PVT LTD