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India CDSCO Guidance: Subject Expert Committee (SEC), What Pharma and Clinical Trial Teams Need to Know
The Central Drugs Standard Control Organization (CDSCO) under India’s Ministry of Health & Family Welfare has released a detailed...
Sharan Murugan
Jul 23, 20252 min read
India CDSCO Guidance: How to Get Export NOC for Approved & Unapproved New Drugs
The Central Drugs Standard Control Organisation (CDSCO) has published a fresh guidance document titled “ Guidance Document for Issuance...
Sharan Murugan
Jul 23, 20252 min read
EMA Guidance: Procedural Advice for Orphan Medicinal Product Designation
The European Medicines Agency (EMA) provides structured guidance for sponsors aiming to secure orphan medicinal product designation...
Sharan Murugan
Jul 19, 20252 min read
UK MHRA Guidance: Use of Real-World Data in Clinical Studies to Support Regulatory Decisions (July 2025 Update)
In July 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released updated and expanded guidance on the use of...
Sharan Murugan
Jul 19, 20253 min read
EMA IRIS Guide: How to Create, Submit and Manage IRIS applications, for Industry and Individual applicants
In the ever-evolving regulatory landscape of EU pharmaceuticals, digital solutions are a linchpin for timely and transparent scientific...
Sharan Murugan
Jul 15, 20252 min read
MHRA’s Guidance: Access, New Active Substance and Biosimilar Work-Sharing Initiatives
In an era of rapid pharmaceutical innovation, global collaboration is key to expediting patient access to new therapies. To help patients...
Sharan Murugan
Jul 15, 20252 min read
Swissmedic Guidnce: A Closer Look at Marketing Authorisation Transfers, DHPC, and RMP Submissions
As the Swiss life sciences sector grows increasingly global and collaborative, Switzerland’s regulatory authority, Swissmedic , continues...
Sharan Murugan
Jul 9, 20252 min read
EMA’s CTIS Framework: Decoding the EMA Clinical Trial Information System-A Practical Guide for Sponsors
In an era of data-driven drug development, the European Medicines Agency (EMA) has launched a transformative regulatory framework : the...
Sharan Murugan
Jul 9, 20252 min read
USFDA’s Draft Guidance: Aluminum Content and Labeling for Small Volume Parenteral Drug Products in Parenteral Nutrition
Aluminum contamination in parenteral nutrition (PN) has long posed a silent but serious risk—especially to vulnerable populations like...
Sharan Murugan
Jul 2, 20253 min read
EMA NDSG Work Plan: Inside the Network Data Steering Group Workplan 2025–2028
In an era where data drives decisions and innovation defines progress, the European Medicines Agency (EMA) and Heads of Medicines...
Sharan Murugan
Jul 2, 20253 min read
USFDA Q&A Guidance: Remote Regulatory Assessments (RRA) and Guidance on Antibacterial Therapies (Q&A) and Early Lyme Disease
The U.S. Food and Drug Administration (FDA) has finalized its guidance document on " Conducting Remote Regulatory Assessments (RRAs) ,"...
Sharan Murugan
Jun 29, 20252 min read
USFDA Guidance: UDI Requirements for Combination Products and Cybersecurity for Medical Devices
In June 2025, the FDA released two impactful draft guidances that significantly affect medical device and combination product...
Sharan Murugan
Jun 29, 20253 min read
ICH E20 Draft Guideline: Understanding Adaptive Clinical Trials in Focus (2025)
The International Council for Harmonisation (ICH) has taken a major step toward modernizing clinical trial designs with the release of the...
Sharan Murugan
Jun 28, 20253 min read
UK MHRA Guidances: 9 important Guidances on Clinical Trials Safety, Approvals, Labelling, and More
Clinical trials are the cornerstone of modern medicine, ensuring that new treatments are safe, effective, and suitable for public use....
Sharan Murugan
Jun 28, 20253 min read
ICH & USFDA Draft Guidance: Q1 Stability Testing: The Gold Standard for Drug Shelf Life and Quality
The stability of drug substances and drug products is a cornerstone of pharmaceutical quality, ensuring that medicines remain safe,...
Sharan Murugan
Jun 23, 20253 min read
EMA Guidance: EMA’s Implementation of ISO IDMP Standards Through Products Management Services (PMS)
To modernize and harmonize the management of medicinal product information, the European Medicines Agency (EMA) is actively implementing...
Sharan Murugan
Jun 23, 20252 min read
USFDA Guidance: Post-Warning Letter Meetings Under GDUFA III: A Regulatory Pathway Toward Compliance
In the evolving regulatory landscape of generic drug manufacturing, compliance and transparency are more crucial than ever. The FDA’s...
Sharan Murugan
Jun 18, 20252 min read
EMA Guidance: A Guide to the HMA-EMA Real-World Evidence Catalogues
As the role of real-world data (RWD) and real-world evidence (RWE) grows in drug development, regulatory decision-making, and...
Sharan Murugan
Jun 18, 20253 min read
UK MHRA Guidance: Get Scientific Advice from MHRA- Comprehensive Guide
Navigating the regulatory landscape for medicines in the UK can be complex, especially as requirements evolve and innovation accelerates....
Sharan Murugan
Jun 18, 20253 min read
UK MHRA Guidance: Electronic Common Technical Document (eCTD) Submissions Update
The Medicines and Healthcare products Regulatory Agency (MHRA) published a key update on 17 June 2025 , outlining revised requirements...
Sharan Murugan
Jun 18, 20252 min read