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Regulatory

Regulatory timeline, process & regulation FAQs
How are applications regarding Clinical Studies done?
Applications regarding Clinical Studies are done online on SUGAM Portal, An e-Governance solution for CDSCO developed by Central Drugs Standard Control Organization (CDSCO).
How do I submit a form to any division of CDSCO?
To submit a form to any of the division of CDSCO, follow below steps:
  • Login with your credentials
  • Go to 'Submit Application' link available on the dashboard.
  • • Select division and the required form and click on the 'Proceed' button. Please ensure that you read the mandatory guidelines displayed on this webpage.
What is the Process of Application on SUGAM Portal.
Online Submission --- Review of Applications --- Track Status of applications---Grant of Permission/ Approval/License/ NOCs
How do I track the status on my submitted application?
You can view status of your submitted applications online. View submitted applications, in the displayed webpage check the 'Status' column to view status of submitted application.
Timelines for above mentioned applications are defined by CDSCO
Important Regulatory for Study in India and abroad
Which are Important Regulatory for Study in India
  • Central Drugs Standard Control Organization (CDSCO)
  • Central Bureau of Narcotics (CBN)
Important Regulatory for Study in abroad
  • US Food and Drug Administration (FDA)
  • Therapeutic Products Directorate (Health Canada)
  • European Medicines Agency (EMA)
  • International Conference on Harmonization (ICH) Therapeutic Goods Administration (TGA)
  • World Health Organization (WHO)
VEEDA’s Regulatory Track Record
Application We Support/Do along with timelines (Veeda)
Sr No. Type of Application Timeline in Days
1 New Drug including Biological, Clinical Trials/Global Clinical trials in consultation with NDAC 90 days
2 IND Application for the drug is discovered in India 90 Days
3 IND Application for research and development of the drug are being done in India and also the drug is proposed to be manufactured and marketed in India 90 days
4 Test License in Form CT-17 for Chemical Test or Analysis, not for Human Use 90 days
5 Test License in Form 11 for Clinical Trial or BA BE study of Old Drugs, on healthy Subject 7 days
6 Test License in Form CT-17 for Clinical Trial or BA BE study of Old Drugs, on Patient 90 days
7 Bioavailability/Bioequivalence (BA BE) Study NOC of New Drugs and IND 90 days
Regulatory – Process How do we get NOC, What the process of submission, timelines of submission, How to start trial for DGCI – timelines
How do we get NOCs/Approvals from DCGI?
Based on the feasibility, recommend to the sponsor and Study objective whether to apply for CTNOC/BENOC/T-License and CBN NOC for Controlled Psychotropic Substances. we have a team who only focuses on the local regulatory requirement which need to be fulfilled before clinical study is initiated.
What are Steps of Submission?
  • Based on the feasibility, recommend to the sponsor whether to apply for BENOC/T-License and CBN NOC for Controlled Psychotropic Substances.
  • Regularly Track the application status to ensure study related approvals are in place in a timely manner in coordination with project management team.
  • To set meetings with DCGI officials if required.
Our preparation to face the continuous regulatory audits
Inspections can occur at any time and we need to be ready to act during any such event. We, at Veeda, believe that Inspection readiness is more than a “one time” event. We ensure following to meet this goal:
  • Adequately trained Staff is available to perform study related activities. Training is ensured by seniors before delegating any study related activities.
  • All study related documents are promptly filed in the Trial Master files and ensured that all these documents are complete with all relevant details.
  • Facility readiness is ensured by continuous verification of the systems and documents.
  • In-house quality monitors team conduct review of processes and documents during study conduct thereby ensure the compliance to study protocol requirements.
  • In-house Quality assurance team conduct system/facility and equipment based audits periodically to check the compliance with in house procedures and Study audits to verify the compliance with study protocol.
  • Senior Management continuously monitors the quality systems of various departments to ensure that all standard processes and practices are implemented, thereby ensuring all time audit readiness of various facilities.

Our exemplary regulatory track record

USFDA
33 times
Brazil ANVISA
7 times
WHO
5 times
UK MHRA
3 times
EU - AGES
1 times
South Africa - MCC
1 times
NPRA - Malaysia
4 times
DCGI
13 times