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.
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What Is a Regulatory Dossier?
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)?
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 Risk Management in Pharma?
What is Risk Management in Pharma? Risk management in the pharmaceutical industry is a structured approach to identifying, assessing, and mitigating potential risks that may affect patient safety, product quality, or regulatory compliance.
What Is EU MDR?
What Is EU MDR? The EU MDR Medical device regulation that came into effect in 2021 reformed the process of medical device and drug-device combination products regulation in the EU. In the case of the pharmaceutical industry, it provides more rigorous questioning, more demanding clinical evidence, and more intensive quality control of each of the… Continue reading What Is EU MDR?
What is a Regulatory Submission?
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 a Quality Management System (QMS)?
What is a Quality Management System (QMS)? Constant quality is essential in the pharmaceutical sector where customer health and product quality are crucial concerns. A Quality Management System (QMS) gives the basis to attain and maintain this quality. It is an integrated set of policies, procedures and processes that govern the entire process of the… Continue reading What is a Quality Management System (QMS)?
What is Regulatory Intelligence in Pharma?
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?
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?
Revised Schedule M: A Strategic Opportunity for India’s Pharma Units
Revised Schedule M: A Strategic Opportunity for India’s Pharma Units The pharmaceutical standards in India are changing, and the revised Schedule M is notified by Government of India as per the Drugs and Cosmetics Rules and is implemented by CDSCO as per DCGI (Drugs Controller General of India) is an indication of the emerging importance… Continue reading Revised Schedule M: A Strategic Opportunity for India’s Pharma Units