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 Agency (EMA), or other national agencies.
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 product lifecycle – its development, manufacturing, packaging and distribution.
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, its manufacturing, testing, and distribution.
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 of quality, safety and global preparedness.