India's Trusted CDSO Partner

Navigate Regulatory Compliance with Confidence

Expert CDSO services for Medical Device registration, Drug approvals, Cosmetic compliance, and BIS/M certification — ensuring your products reach the market faster.

500+
Successful Registrations
15+
Years Experience
98%
Approval Rate
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Medical Device Registration
CDSCO Class I, II, III & IV
ACTIVE
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Drug Registration
Form 41 / New Drug Applications
ACTIVE
Cosmetic Compliance
Schedule S, Import & License
ACTIVE
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BIS/M Certification
IS Standards & ISI Mark
ACTIVE

Comprehensive Regulatory Services

End-to-end support from pre-submission strategy to post-market compliance across all regulated product categories.

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Medical Device Registration

Complete CDSCO registration support for all classes of medical devices including in-vitro diagnostics. We handle documentation, clinical data, and regulatory liaison.

Class I / II / III / IVIVD DevicesImport LicenseLoan LicenseMD-14 / MD-15
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Drug Registration

Expert guidance through India's drug approval framework — from the Drugs & Cosmetics Act, 1940 to New Drugs & Clinical Trials Rules, 2019. We handle all licence categories.

D&C Act, 1940 Drugs Rules, 1945 NDCT Rules, 2019 Form 41 Import New Drug NDA Biologicals
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Cosmetic Registration

Full compliance support for cosmetic products under the Drugs & Cosmetics Act and Cosmetics Rules, 2020 — import registration, labeling review, and Schedule S compliance.

Schedule SImport LicenseLabel ReviewSafety AssessmentBIS Cosmetics
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BIS / BIS-M Certification

Bureau of Indian Standards certification for medical devices and healthcare products. We manage the complete application, factory audit preparation, and ISI mark licensing.

ISI MarkIS StandardsFactory AuditCRS (Electronics)Foreign MFR

Our Proven 5-Step Process

A structured approach that minimizes delays and maximizes your approval success rate.

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Step 01
Gap Analysis

Review existing documentation and identify gaps against CDSCO / BIS requirements.

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Step 02
Dossier Preparation

Compile technical files, clinical data, testing reports, and regulatory submissions.

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Step 03
Authority Submission

Submit to CDSCO / BIS and manage entire communication with regulators.

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Step 04
Query Resolution

Respond promptly to regulatory queries with detailed, data-backed justifications.

Step 05
Approval & PMS

Obtain registration certificate and support post-market surveillance compliance.

We Navigate India's Complex Regulatory Landscape

Deep expertise across all key Indian regulatory frameworks for medical products.

CDSCO

Central Drugs Standard Control Organization

National regulatory body for drugs, cosmetics, medical devices & diagnostics under MOHFW.

MDR 2017

Medical Devices Rules, 2017

Comprehensive framework for classification, registration, manufacturing and import of medical devices.

D&C Act

Drugs & Cosmetics Act, 1940

Primary legislation governing the import, manufacture and distribution of drugs and cosmetics in India.

BIS Act

Bureau of Indian Standards Act, 2016

Mandatory ISI certification under IS standards for notified medical devices and products.

Approval Success Metrics

Client approval rates across product categories

Medical Devices (Class I & II)99%
Medical Devices (Class III & IV)94%
Drug Registration (Import)97%
Cosmetic Compliance100%
BIS / BIS-M Certification95%

Based on 500+ filings. 2009–2024.

What Sets Us Apart

A dedicated team with deep regulatory intelligence and a track record of swift approvals.

Faster Timelines

Our pre-built templates and established authority relationships significantly reduce standard approval timelines.

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Specialist Team

Ex-CDSCO officials and former pharma regulatory heads with direct experience in the Indian approval system.

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Confidentiality

All client data, formulations, and technical documents are protected under strict NDAs and secure systems.

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Global Clients

We serve international manufacturers from USA, Europe, Japan and South Korea seeking India market entry.

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Dedicated Manager

Every client gets a single point of contact who tracks your application status and keeps you updated.

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Post-Market Support

Ongoing pharmacovigilance, renewal tracking, adverse event reporting, and label change management.

Get In Touch

Start Your Registration Journey

Book a free 30-minute consultation with our regulatory experts. No obligation, just clarity on your path to approval.

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Head Office

Connaught Place, New Delhi — 110001, India

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Phone / WhatsApp

+91 98100 00000

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Email

info@regpathcdso.in

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Working Hours

Mon – Sat: 9:00 AM – 6:30 PM IST