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CDSCO Licensing
CDSCO / DCGI β€” Regulatory Consultants

CDSCO Licensing for Drugs, Devices & Cosmetics

πŸ’ŠDrug LicenseπŸ’„Cosmetic LicenseπŸ”¬Medical DevicesπŸ₯DCGI Approvalβœ…0% Failure Rate
⚑
30d–6m
Processing Time
πŸ”¬
3
Device Classes (B–D)
πŸ†“
Free
Initial Consultation
❌
0%
Failure Rate
CDSCO / DCGI

End-to-End CDSCO Compliance, Handled for You

Regulatory approvals for pharmaceutical drugs, cosmetics, and medical devices under CDSCO / DCGI. We manage the complete licensing journey β€” from product classification to final approval.

Our CDSCO specialists handle technical dossier preparation, Sugam portal filing, query response management, and liaison with the Drug Controller β€” so you can focus on bringing your products to market.

CDSCO compliance lab
Trusted by Pharma & MedTech Companies

Drug License Β· Cosmetic License Β· Medical Devices Β· DCGI Approval

Quick Info
Governing BodyCDSCO / DCGI
Governing ActDrugs & Cosmetics Act, 1940
Device RulesMedical Devices Rules 2017
Processing Time30 Days – 6 Months
Applicable ToDrugs, Cosmetics & Devices
CDSCO Services

CDSCO Licensing Services

Comprehensive regulatory services for drugs, cosmetics, and medical devices in India.

πŸ’Š
Pharma

Drug License

Manufacturing or import license for pharmaceutical drugs and formulations under Drugs & Cosmetics Act.

πŸ’„
Cosmetics

Cosmetic License

Import or manufacturing license for cosmetic products sold in India under CDSCO regulations.

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Medical

Medical Device Registration

Registration for medical devices including Class A, B, C & D devices under MDR 2017.

πŸ“‹
Imports

CDSCO Import License

Import license for drugs, cosmetics and medical devices under Form 10 / Form 8 procedures.

πŸ₯
New Drugs

DCGI Approval

Approval from Drug Controller General of India for new drugs, biologicals and clinical trials.

πŸ§ͺ
Research

Clinical Trial Approval

CDSCO approval for conducting clinical trials in India for new drugs and medical devices.

Application Process

CDSCO Application Process

πŸ“Œ
Step 01

Product Classification

We classify your drug/device/cosmetic under the appropriate CDSCO category and identify the correct application type.

πŸ“‘
Step 02

Technical Dossier

Preparation of complete technical dossier as per CDSCO requirements β€” CTD format for drugs.

πŸ“€
Step 03

Application Filing

Complete application filed on the Sugam portal (CDSCO) or physically with the licensing authority.

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Step 04

Query Response

CDSCO may raise technical queries. We prepare detailed, accurate responses to avoid delays.

βœ…
Step 05

License Issued

CDSCO issues the drug/device license or registration certificate upon successful review.

Documents
Required Documents

Documents Required

βœ“
Company registration & GST certificate
βœ“
Product composition & formulation details
βœ“
GMP certificate / manufacturing license
βœ“
Clinical/safety data (for new drugs)
βœ“
Authorized Indian agent details
βœ“
Site Master File (SMF) for manufacturers
βœ“
Certificate of Pharmaceutical Product (CoPP)
βœ“
Stability data and shelf-life information

Not sure if you have everything?

CDSCO FAQ
Frequently Asked

CDSCO Licensing FAQs

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Navigate CDSCO with Confidence

Our regulatory experts will guide you through every step of the CDSCO approval process.
Free consultation. Transparent pricing. Error-free dossiers.

πŸ“ž +91-9891229135