Category: Regulatory

How to read a CEP – European Directorate for the Quality of Medicines(EDQM) Overview: Aim and scope of EDQM policy document PA/PH/CEP(15)31 “How to read a CEP” How to interpret the information laid down on CEPs

Regulatory Submissions Management: Driving Compliance and Speed in Global Markets These days, rules around the world keep getting stricter. If you’re trying to launch a new drug, medical device, or even a cosmetic, you can’t afford to mess up your regulatory submissions management process. Getting these submissions right quickly and by the book makes all… Continue reading Regulatory Submissions Management: Driving Compliance and Speed in Global Markets

EDQM GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF CERTIFICATES OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA MONOGRAPHS EDQM Guideline Revision: The European Directorate for the Quality of Medicines & HealthCare (EDQM) has revised the “Guideline on requirements for revision and renewal of certificates of suitability to the European Pharmacopoeia monographs” (PA/PH/CEP (04) 02) to align it with… Continue reading EDQM GUIDELINE ON REQUIREMENTS FOR REVISION/RENEWAL OF CERTIFICATES OF SUITABILITY TO THE EUROPEAN PHARMACOPOEIA MONOGRAPHS

What is a Common Technical Document (CTD)? Pharmaceutical companies seeking global market approval must navigate complex regulatory requirements. To simplify submissions and harmonize standards, the International Council for Harmonisation (ICH) introduced the Common Technical Document (CTD). This format has become the backbone of regulatory filings worldwide, ensuring consistency, efficiency, and transparency in drug approval processes.

What is an Investigator’s Brochure (IB)? Clinical trials are the foundation of pharmaceutical innovation, and their success depends on clear communication between sponsors and investigators. The Investigator’s Brochure (IB) is a critical document that provides comprehensive information about an investigational product, ensuring that clinical trial teams understand its properties, risks, and potential benefits. It serves… Continue reading What is an Investigator’s Brochure (IB)?

What is Document Management System (DMS)? In the pharmaceutical industry, documentation is the backbone of compliance, quality assurance, and regulatory approval. Every stage of drug development—from research to manufacturing—requires meticulous records.

What is a Regulatory Gap Analysis? In the pharmaceutical industry, compliance with evolving global regulations is critical to ensure patient safety, product quality, and uninterrupted market access. A Regulatory Gap Analysis is a systematic process used by pharma companies to identify discrepancies between current practices and regulatory requirements.

What Is a Regulatory Dossier? In the pharmaceutical industry, the development and approval of medicinal products depend heavily on the quality and completeness of regulatory documentation. One of the most critical components of this documentation is the regulatory dossier.

What is a Certificate of Free Sale (CFS)? In the pharmaceutical industry, international trade requires strict documentation to ensure product safety and compliance. One of the most important documents for exporting medicines and healthcare products is the Certificate of Free Sale (CFS).

What is a Regulatory Submission? In the pharmaceutical industry, bringing a new drug or medical product to market requires strict adherence to global regulatory standards. A regulatory submission is the formal process by which pharmaceutical companies present comprehensive data packages to health authorities, such as the U.S. Food and Drug Administration (FDA), the European Medicines… Continue reading What is a Regulatory Submission?