CDSCO Approved Laboratory

CDSCO Approved Testing Laboratory in India | Auriga Research

NABL-accredited labs with CDSCO approvals for pharmaceutical testing, medical device testing, and clinical research — Delhi, Manesar, and Bahadurgarh.

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CDSCO Approvals at Auriga

CDSCO is a regulatory approval authority — not an accreditation body like NABL. CDSCO covers several distinct approval types under the Drugs and Cosmetics Act. Each Auriga lab holds the specific approval(s) listed below, and each approval type has its own scope.

CDSCO Approval

MD-40 Medical Device Testing

Labs: Delhi and Bahadurgarh

Approval for testing medical devices under the Medical Devices Rules 2017 — biocompatibility, packaging, sterility, and device-grade material work for CDSCO medical device registration dossiers.

CDSCO Approval

Form-37 Drug Licence

Labs: Delhi, Manesar, and Baddi

Drug Licence approval under the Drugs and Cosmetics Act for testing pharmaceutical raw materials and finished products — assay, related substances, dissolution, stability, and impurity work.

CDSCO Approval

DCGI Approved CRO

Labs: Manesar — Clinical Research Division

DCGI approval for CRO activities at the Manesar (IMT Manesar, Plot 136, Sector 5) Clinical Research Division — clinical trials, BA/BE studies, and PK/PD work. Held continuously since 1995.

CDSCO Approval

CDSCO/DCGI Clinical Studies

Labs: Manesar

CDSCO/DCGI approval for conducting clinical studies at the Manesar CRD — supporting Sugam-portal clinical trial applications since 2000.

Distinct approval types: MD-40, Form-37 Drug Licence, DCGI CRO Approval, and CDSCO clinical-study approval are four separate regulatory approvals with separate scopes. Quotes specify the approval type relevant to your dossier and the lab that holds it.

When You Need CDSCO-Approved Lab Reports

Four common dossier and registration scenarios where the testing lab must hold a specific CDSCO approval.

CDSCO Drug Registration Dossier

Stability, assay, and impurity data for a CDSCO drug registration dossier must come from a Form-37 approved laboratory. Auriga Delhi, Manesar, and Baddi hold Form-37 Drug Licence approvals.

Medical Device CDSCO Submission

Biocompatibility, bioburden, and packaging testing for a medical device CDSCO submission must come from an MD-40 registered lab. Auriga Delhi and Bahadurgarh hold MD-40 approval.

Clinical Trial Application via Sugam

A clinical trial application submitted to CDSCO via the Sugam portal requires a DCGI-approved CRO. Auriga's Manesar CRD has held DCGI approval since 1995 and CDSCO clinical study approval since 2000.

CDSCO Import Registration for Cosmetics

CDSCO import registration applications for cosmetics require testing at a CDSCO-approved laboratory. Auriga Delhi supports cosmetic import dossier testing under the Cosmetics Rules 2020.

Lab-wise CDSCO Approvals

Every Auriga lab holding a CDSCO approval, the approval type, the scope, and the year the approval has been held. Year fields marked "Confirm year" to be confirmed with the lab team before go-live.

Lab Approval Type Scope Since
Delhi MD-40 Medical Device Medical device testing Confirm year
Delhi Form-37 Drug Licence Pharma raw material and finished product Confirm year
Manesar Form-37 Drug Licence Pharma testing Confirm year
Manesar DCGI CRO Approval Clinical trials, BA/BE, PK/PD 1995
Manesar CDSCO CRO Approval Clinical studies 2000
Baddi Form-37 Drug Licence Pharma testing Confirm year
Bahadurgarh MD-40 Medical Device Medical device testing Confirm year

CDSCO Approval Letters and Form-37 Licences

CDSCO approval letters, Form-37 Drug Licences, and the DCGI CRO approval for Manesar are available for vendor qualification, due diligence, regulatory submissions, and tender requirements.

View CDSCO Approval Letters and Form-37 Licences

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Pharmaceutical Testing Services View → Medical Device Testing Services View → Clinical Trials at Manesar View → View All Our Accreditations View →

Get a CDSCO-Accepted Test Report

MD-40 medical device, Form-37 pharma, and DCGI CRO approvals across Delhi, Manesar, Baddi, and Bahadurgarh. NABL accredited. Reports formatted for CDSCO Sugam-portal and dossier submissions.

+91-7428116100 Get a CDSCO-Accepted Report

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