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Monday 9am - 6pm Tuesday 9am - 6pm Wednesday 9am - 6pm Thursday 9am - 6pm Friday 9am - 6pm

CliniExperts Services Pvt. Ltd.

Name: CliniExperts Services Pvt. Ltd.
Address: Unit No. 325, City Centre Mall, Plot No. 5, Sector 12, Dwarka, Delhi, 110075, IN
Telephone: +917672005050
Price range: £

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CliniExperts Services Pvt. Ltd.

We are regulatory solutions provider catering to a vast array of services lines and products to simp

CliniExperts is India’s leading regulatory solutions provider recognized for its meritocracy, stringent QA and QC standards, up-to-the-minute knowledge base, professionalism and unquestionable ethics. It offers end-to-end regulatory solutions to pharma, food, cosmetic, medical devices, nutraceuticals, biological & vaccines industries.

02/04/2025

CDSCO Unveils Online Platform for MSMEs to Seek Schedule M Compliance Extension.

Small and medium pharma firms can now apply online for an extension on revised Schedule M compliance. The new CDSCO system streamlines submissions with a deadline set for Dec 31, 2025.

Click for more information: - https://cliniexperts.com/regulatory-update/cdsco-launches-online-system-for-msmes-to-request-extension-on-revised-schedule-m-compliance/

25/03/2025

CDSCO Launches Online System for MSMEs to Request Extension on Revised Schedule M Compliance

The CDSCO has introduced the Online National Drugs Licensing System (ONDLS) for submitting applications to extend the deadline for small and medium pharmaceutical units to meet the revised Schedule M manufacturing standards.

This follows a Ministry of Health notification extending the compliance deadline for MSMEs to December 31, 2025.

Applicants are required to submit their requests online within three months of the notification and provide a detailed plan outlining the necessary upgrades to meet Good Manufacturing Practices (GMP).

Applicants must submit a detailed plan in prescribed Form A within three months, including a gap analysis and a compliance plan.

However, challenges have been raised regarding the requirement to apply to the Central License Approving Authority and the complexity of meeting the detailed application requirements.

Click for more info:- https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTI1ODQ=

24/03/2025

India Enforces Ban on Harmful Antibiotics in Livestock – Details Inside.

The Ministry of Health bans Chloramphenicol & Nitrofurans in food animals to prevent antibiotic contamination in meat and dairy. Explore the implications of this regulation.

Click for more info:- https://cliniexperts.com/regulatory-update/ban-on-chloramphenicol-and-nitrofurans-in-food-producing-animals/

21/03/2025

Important Update for Clinical Research Organizations (CROs) in India!

Attention CROs! A new regulatory requirement has been introduced by the Ministry of Health and Family Welfare (MoHFW) under G.S.R No. 581(E) dated 19/09/2024. From now on, all Clinical Research Organizations (CROs) must register with CDSCO to stay compliant and operate smoothly in India.

CliniExperts is here to help! Our experts can assist you with the Registration process and ensure everything is in place.

Click on the link to see the update:
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTI1Njk=

14/03/2025

HAPPY HOLI !!!

13/03/2025

CDSCO No Objection Certificate (NOC) for Drug Export – Requirements & Process.

Find out how manufacturers can obtain an Export NOC for unapproved and approved new drugs, including submission guidelines and verification steps.

Get details:- https://cliniexperts.com/regulatory-update/summary-of-guidance-document-for-issuance-of-no-objection-certificate-for-manufacture-of-unapproved-approved-new-drugs-for-export-purpose/

13/03/2025

CDSCO SUGAM Portal Guide: CRO Registration & Form CT-07B Submission.

Find out how to register or renew a CRO on the SUGAM Portal, including step-by-step instructions for Form CT-07B and essential compliance guidelines.

Clink link:- https://cliniexperts.com/regulatory-update/guide-to-cro-registration-on-sugam-portal/

12/03/2025

New Quarterly Returns Format for Psychotropic Substance Manufacturers – Update 2025.

The latest format for Quarterly Returns for Bulk Psychotropic Substance Manufacturers is now available. Stay updated on submission guidelines and compliance requirements.

More information:- https://cliniexperts.com/regulatory-update/new-format-of-quarterly-returns-for-manufacturers-of-bulk-psychotropic-substances-and-manufactures-of-preparations-of-psychotropic-substances/

12/03/2025

FSSAI Drafts Vegan Foods Amendment Regulations 2025 – Key Updates & Compliance.

The FSSAI proposes the Vegan Foods Amendment Regulations 2025, mandating import certificates from recognized authorities. Learn key updates and compliance details.

Get more information:- https://cliniexperts.com/regulatory-update/draft-food-safety-and-standards-vegan-foods-amendment-regulations-2025/

10/03/2025

Streamlining Clinical Trials: Add Sites & Change PI Easily on Sugam Portal.

Navigate the regulatory process for clinical trial site additions and principal investigator changes with ease using the Sugam Portal.

Get details:- https://cliniexperts.com/regulatory-update/clinical-trial-site-addition-and-change-of-principal-investigator-for-all-clinical-trials-through-sugam-portal/

10/03/2025

Regulatory Update: New Drug Classification for Enteric-Coated & Delayed-Release Drugs.

State Drug Controllers must uniformly implement NDCT Rules 2019, ensuring all modified-release drugs, including gastro-resistant formulations, are treated as new drugs.

Click link:- https://cliniexperts.com/regulatory-update/gastro-resistant-tablets-capsules-delayed-release-tablets-capsules-consider-as-new-drugs-under-ndct-rules-2019/

08/03/2025

Invitation for Comments: Draft IVD-MD Adverse Event Reporting Form.

The Indian Pharmacopoeia Commission (IPC) has released a draft adverse event reporting form for in-vitro diagnostic medical devices.

Manufacturers and healthcare professionals are encouraged to provide feedback by March 5, 2025.

Get more information:- https://cliniexperts.com/regulatory-update/draft-in-vitro-diagnostic-medical-device-ivd-md-adverse-event-reporting-form-for-comments/

Address

Unit No. 325, City Centre Mall, Plot No. 5, Sector 12, Dwarka
Delhi
110075

Opening Hours

Monday	9am - 6pm
Tuesday	9am - 6pm
Wednesday	9am - 6pm
Thursday	9am - 6pm
Friday	9am - 6pm

Telephone

+917672005050

Website

https://cliniexperts.com/

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