Author: masuuglobal

Understanding Clinical Regulatory Affairs in the Pharmaceutical Industry The pharmaceutical and healthcare industries operate in one of the most highly regulated environments in the world. Clinical regulatory affairs plays a critical role in ensuring that new medicines, biologics, and medical devices meet strict safety, efficacy, and quality standards before reaching patients.

Internal Audit and Compliance: Strengthening Regulatory Readiness In today’s highly regulated industries, internal audit and compliance play a critical role in maintaining operational integrity and meeting legal obligations. Organizations operating under strict regulatory compliance requirements must ensure that their systems, processes, and documentation consistently align with applicable standards and laws.

21 CFR Part 11 Validation: Ensuring Compliance with FDA Regulations In today’s regulated life sciences environment, 21 CFR Part 11 validation is critical for companies managing electronic records and electronic signatures. Under FDA 21 CFR Part 11, organizations must ensure that electronic systems are secure, reliable, and capable of maintaining data integrity in accordance with… Continue reading 21 CFR Part 11 Validation: Ensuring Compliance with FDA Regulations

What Is an Investigational New Animal Drug (INAD)? A Regulatory Pathway for Veterinary Drug Development Veterinary medicinal products require rigorous testing to ensure that they are safe and effective for use in animals. In the United States, the development of new animal drugs is governed by the U.S. Food and Drug Administration (FDA) under the… Continue reading What Is an Investigational New Animal Drug (INAD)

What Is Corrective Action and Preventive Action (CAPA)? A Critical Quality Management Process in Life Sciences Staying on top of regulatory standards is a must in pharmaceuticals, biotech, and medical devices. When quality issues pop up, companies turn to Corrective Action and Preventive Action better known as CAPA. It’s not just a checkbox, either. CAPA… Continue reading What Is Corrective Action and Preventive Action (CAPA)?

Clarification on the Use of the Sister File Procedure-EDQM The current EDQM policy PA/PH/CEP (09) 141, 2R, “Guidance on applications for “sister files”, has guided the sister file procedure for CEPs for many years. Experience gathered over time indicates that there may be discrepancies in the understanding of the procedure and the EDQM has noted… Continue reading Clarification on the Use of the Sister File Procedure-EDQM

IMPLEMENTATION OF THE EUROPEAN PHARMACOPOEIA SUPPLEMENT 12.3 Publication schedule:  Issue Publication date Correction date Implementation date 12.1 07/2025 31/08/2025 01/01/2026 12.2 10/2025 30/11/2025 01/04/2026 12.3 01/2026 28/02/2026 01/07/2026 13.1 04/2026 31/05/2026 01/01/2027 13.2 07/2026 31/08/2026 01/04/2027  

What Is an Investigational Device Exemption (IDE)? Enabling Clinical Trials for Medical Devices in the U.S. If you intend to sell a medical device in the United States, it is necessary to prove it is safe and operates as intended. Before doctors can test a new device on people, the company behind it usually needs… Continue reading What Is an Investigational Device Exemption (IDE)?

What Is an Individual Case Safety Report (ICSR)? A Key Component of Pharmacovigilance Pharmacovigilance plays a vital role in overseeing the safety of medicinal products during the lifecycle of the products. The Individual Case Safety Report (ICSR) is considered to be one of the most significant tools that are employed to monitor and analyze adverse… Continue reading What Is an ICSR

What Is an IMPD? Understanding the Investigational Medicinal Product Dossier Regulatory approval is a pre-requisite prior to initiating any clinical trial that involves any medicinal products in the European Union. Among the most significant papers needed in this procedure is Investigational Medicinal Product Dossier (IMPD).