Regulatory Affairs · CDSCO · Global
End-to-End Regulatory Compliance Services for India and Global Markets
Shen Clinical Services provides regulatory affairs services that guide drugs, biologics, medical devices, diagnostics and cosmetics through approval and keep them compliant afterwards. Our regulatory affairs team plans your pathway, prepares the dossier, files on CDSCO’s SUGAM portal, handles queries and Subject Expert Committee reviews, and supports submissions to the US FDA, EMA and MHRA.
CDSCO and SUGAMIndian approvals filed online
NDCT Rules, 2019Drugs and clinical trials
MDR 2017, Cosmetics Rules 2020Devices, IVDs and cosmetics
FDA · EMA · MHRAGlobal submissions
On this page
CDSCO Approvals
CDSCO Approvals We Manage
From clinical trial regulatory services to product registration in India and import licensing, we prepare, file and track every major CDSCO application. Target timelines are from CDSCO’s Citizen Charter (2025):
| Approval | Application to grant | CDSCO target |
|---|---|---|
| Clinical trial permission | Form CT-04 to Form CT-06 | 90 working days |
| Investigational new drug (with expert committee) | NDCT Rules, 2019 | 30 working days |
| New drug for import or manufacture | Form CT-18 (import) or CT-21 (manufacture) | 90 working days |
| Subsequent new drug and FDC approvals | NDCT Rules, 2019 | 90 working days |
| Drug import registration certificate | Form 40 to Form 41 | 270 working days |
| Drug import licence | Form 8 to Form 10 | 45 working days |
| Medical device import licence | Form MD-14 to MD-15 | 270 working days |
| Cosmetic import registration | Form COS-1 to COS-2 | 180 working days |
The clock pauses while a CDSCO query is open, so complete dossiers and fast responses keep you on target.
Across the Lifecycle
Regulatory Affairs Services Across the Product Lifecycle
Regulatory Strategy and Gap Analysis
We map the fastest compliant pathway, including local trial waivers under Rule 101, and identify gaps in your data before you file.
Dossier Preparation
CTD Modules 1 to 5 written and assembled to ICH M4, covering clinical and non-clinical summaries, with India-specific Module 1 documents.
Submission and Query Management
Filing on SUGAM, fee payment, tracking, query responses and Subject Expert Committee presentations.
Post-Approval Lifecycle
Variations, endorsements, renewals, labelling updates and pharmacovigilance obligations.
Global Markets
Global Regulatory Submissions: FDA, EMA, MHRA and More
Taking an Indian product abroad, or a global product into India? We prepare and review submissions for:
- United States: US FDA IND, NDA and BLA dossiers
- European Union: EMA marketing authorisation applications
- United Kingdom: MHRA submissions
- Switzerland and Canada: Swissmedic and Health Canada
- WHO: WHO prequalification of medicines, vaccines and diagnostics
Our Process
How Our Regulatory Compliance Process Works
STEP 01
Assess
We review your product, data and target markets, and confirm the classification and approvals you need.
STEP 02
Plan
We agree a regulatory strategy, document list and timeline, and flag any risks early.
STEP 03
Submit
We prepare the dossier, file it, and manage every query and committee review until approval.
STEP 04
Maintain
We handle changes, renewals and compliance reporting for the life of the product.
Why Shen
Why Choose Shen for Regulatory Affairs Services in India
Looking for a CDSCO regulatory consultant who can also run the science behind your dossier? Here is what sets our end-to-end regulatory compliance services apart:
Up-to-Date Regulatory Intelligence
We track CDSCO notifications, such as the 2026 NDCT amendments, and tell you what they mean for your products.
Physician-Led Scientific Input
Clinicians shape the clinical arguments in your dossier and committee presentations.
India and Global in One Team
CDSCO, FDA, EMA and MHRA requirements planned together, so one data package works everywhere.
Ready-to-Use Tools
Checklists and templates that cut preparation time and reduce queries.
What We Cover
Our Regulatory Affairs and Compliance Services
CDSCO regulatory strategy
Clinical trial applications
New drug approvals
SND and FDC approvals
Import registration and licences
Test licences and prior intimations
Medical device and IVD licensing
Cosmetic registration
Indian Authorized Agent
CTD dossier preparation
FDA, EMA and MHRA submissions
Post-approval changes and renewals
FAQs
Regulatory Affairs Services: Frequently Asked Questions
What do regulatory affairs services include?
Regulatory affairs services cover regulatory strategy, dossier preparation, submissions to regulators such as CDSCO, US FDA and EMA, responses to queries, and the post-approval changes, renewals and compliance that keep a product on the market. Shen provides these clinical and non-clinical regulatory services for drugs, biologics, medical devices, diagnostics and cosmetics.
How long does CDSCO take to approve a new drug?
Under CDSCO’s Citizen Charter (2025), the targeted timeline for new drug, clinical trial and new claim applications reviewed by the Subject Expert Committee is 90 working days. The clock pauses while a query is open and restarts when CDSCO receives your response, so a complete dossier matters.
What is the SUGAM portal?
SUGAM is CDSCO’s online portal for filing applications, paying fees, answering queries and receiving approvals for drugs, clinical trials, medical devices and cosmetics. Most CDSCO applications must now be filed through it.
What is CDSCO’s Subject Expert Committee?
Subject Expert Committees (SECs) are panels of specialists in each therapeutic area that review new drug and clinical trial applications and advise CDSCO. Sponsors are often asked to present their data to the SEC, and good preparation can shorten the review.
Can a local clinical trial be waived for approval in India?
Rule 101 of the New Drugs and Clinical Trials Rules, 2019 lets CDSCO consider waiving a local trial for drugs already approved in notified countries. It is decided case by case, and CDSCO may ask for a Phase IV study after approval.
What changed in Indian drug regulation in 2026?
The NDCT (Amendment) Rules, 2026 moved most test licences for trial supplies to online prior intimation (G.S.R. 46(E)), and eligible export BA/BE studies now need only prior intimation (G.S.R. 50(E)). Clinical trial and new drug approval processes are unchanged.
Resource Spotlight
Know your product type? See our dedicated pages for clinical trials in India, IVD registration, biologics registration services in India, medical device registration, cosmetic registration in India and Indian Authorized Agent services.
Get Your Product Approved and Keep It Compliant
Planning a submission? Ask for a regulatory pathway assessment and timeline.
Stuck with a CDSCO query? Our team can review it and prepare your response.
+91 98968 89927 · info@shenclinicalservices.com · A 302, Urban Square, Sector-62, Gurugram, Haryana 122098
Sources: CDSCO Citizen Charter (2025); CDSCO clinical trials and NDCT Rules, 2019; ICH M4 Common Technical Document; NDCT (Amendment) Rules, 2026. General regulatory information, not legal advice.