Category: Regulatory

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?

What is Regulatory Intelligence in Pharma? Regulatory intelligence (RI) has become a cornerstone for pharmaceutical companies navigating the highly regulated global landscape. It refers to the systematic process of gathering, analyzing, and applying information about current and emerging regulations, guidelines, and industry standards to ensure compliance, accelerate product development, and support market access.

What is Regulatory Compliance? Regulatory compliance in the pharmaceutical industry is the conformity to the laws, guidelines and standards that are set by the authorities that control the safety, efficacy and quality of pharmaceutical products. The regulations protect the health of the population as stringent control can be maintained during the design of the drug,… Continue reading What is Regulatory Compliance?

Streamlining Change: New EU Guidelines Simplify Medicines Lifecycle Management EMA welcomes the publication of the European Commission’s (EC) new Variations Guidelines, which streamline the lifecycle management of medicines (see EC news). These EU Variation guidelines will support the implementation of the new Variations Regulation that came into force in 15 January 2025.

Changes to e-Submission Requirements for CEP Applications As part of continuous digital transformation in regulatory processes, the European Directorate for the Quality of Medicines & HealthCare (EDQM) has introduced automation to enhance the management and review of Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEP) submissions.

What is Clinical Regulatory Writing? Clinical Regulatory Writing is a highly specialized type of medical writing which facilitates the development, approval and post marketing surveillance of drugs and medical devices. It includes developing the necessary materials needed by international health regulators, including the FDA, EMA, and MHRA, when performing the clinical trial and regulatory submission… Continue reading What is Clinical Regulatory Writing

What is a Drug Regulatory Authority? In the pharmaceutical sector, integrity of drug development, production, and distribution matters most. The main role of Drug Regulatory Authority (DRA) is to ensure that the pharmaceutical product is of the set standard of safety, quality and efficacy.

What is Claim Substantiation? Claim substantiation in pharmaceutical business is a very important process whereby all claims that are related to products such as therapeutic, preventive and supportive ones are supported by reliable scientific facts. The practice is not only a regulatory liability but also a pillar of an ethical marketing practice and patient safety.