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Regulatory Update on Examination of 2nd Assessment Report by Prof. Kokate Committee

Posted by: admin April 18, 2025

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18th April, 2025

CDSCO Issues Guidelines for Transfer of Drugs from SEZ to Domestic Tariff Area

Posted by: admin April 16, 2025

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16th April, 2025

CDSCO Proposes Risk Class Updates and new entries in Cardiovascular and Neurological Devices

Posted by: Hitesh Gupta April 8, 2025

New format of Quarterly Returns for Manufacturers of Bulk Psychotropic substances and Manufactures of Preparations of Psychotropic Substances

Posted by: Hitesh Gupta March 12, 2025

Guide to CRO Registration on SUGAM Portal

Posted by: Hitesh Gupta March 12, 2025

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12th March, 2025

Summary of Guidance Document for Issuance of No Objection Certificate for Manufacture of Unapproved/Approved New Drugs for Export Purpose

Posted by: Hitesh Gupta March 12, 2025

Gastro Resistant Tablets/Capsules Delayed Release Tablets/Capsules consider as New Drugs under NDCT rules, 2019

Posted by: Hitesh Gupta March 8, 2025

Clinical trial site addition and change of principal Investigator for all Clinical Trials through sugam Portal

Posted by: Hitesh Gupta March 8, 2025

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Regulation/Guidelines

Organic Food Labelling In India| Certification, and Import of Organic Food in India

This Article is All About Organic Food Labelling In India and Certification, and Import of Organic Food in India. Explained in Detail About What is Organic Food labelling? Summary Organic...

21st April, 2025

Regulation/Guidelines

Cosmetic Label Compliance India : A Guide to Compliance

Introduction Looking for Cosmetic Label Compliance India? Are you a cosmetic manufacturer or importer navigating the complex world of Indian regulations? Ensuring your product labels comply with the latest cosmetic...

26th March, 2025

Regulation/Guidelines

Clinical Investigation Approvals: An Overview of Forms MD-22 and MD-23

Summary As per MDR 2017, “clinical investigation” means the systematic study of an investigational medical device in or on human participants to assess its safety, performance or effectiveness. Clinical investigations...

15th January, 2025

Regulation/Guidelines

Regulatory Challenges of SaMD: Navigating Global Standards and Compliance

Overview Navigating Software as a Medical Device regulation involves addressing varying global standards, including risk-based classifications. Challenges include managing risks, demonstrating clinical evidence, and ensuring data security. Harmonisation efforts and...

4th November, 2024

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Regulatory Update on Examination of 2nd Assessment Report by Prof. Kokate Committee

CDSCO Issues Guidelines for Transfer of Drugs from SEZ to Domestic Tariff Area

CDSCO Proposes Risk Class Updates and new entries in Cardiovascular and Neurological Devices

New format of Quarterly Returns for Manufacturers of Bulk Psychotropic substances and Manufactures of Preparations of Psychotropic Substances

Guide to CRO Registration on SUGAM Portal

Summary of Guidance Document for Issuance of No Objection Certificate for Manufacture of Unapproved/Approved New Drugs for Export Purpose

Gastro Resistant Tablets/Capsules Delayed Release Tablets/Capsules consider as New Drugs under NDCT rules, 2019

Clinical trial site addition and change of principal Investigator for all Clinical Trials through sugam Portal

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