Author: masuuglobal

What Is FDA Drug Approval? FDA drug approval refers to the procedure in which the FDA assesses a novel medicine to ascertain whether it is effective and safe for the targeted objective. This procedure requires thorough research, trials, and the assessment of the approaches used by the relevant authorities before a drug can be offered… Continue reading What Is FDA Drug Approval?

What is a Master Validation Plan (MVP)? In the pharmaceutical industry, maintaining product quality, regulatory compliance, and patient safety is non-negotiable. A Master Validation Plan (MVP) serves as the foundation for organizing and controlling all validation activities within a manufacturing facility.

What is Post-Market Surveillance? Post-Market Surveillance (PMS) is a crucial process in the pharmaceutical industry that ensures medicines remain safe, effective, and compliant even after they are launched in the market.

What is a DHF(Design History File)? Developing pharmaceutical products requires more than innovation, it demands complete documentation, regulatory compliance, and unwavering quality assurance.

FDA Announces Generic Drug User Fee Rates for Fiscal Year 2027 (FY 2027) The U.S. Food and Drug Administration (FDA) has released the FY 2027 Generic Drug User Fee Rates published under the Generic Drug User Fee Amendments of 2022 (GDUFA III).

What Is SAHPRA? A Complete Guide to South Africa’s Health Products Regulatory Authority The pharmaceutical industry depends on strong regulatory systems to ensure that medicines and medical products are safe, effective, and of high quality. In South Africa, this responsibility lies with the South African Health Products Regulatory Authority (SAHPRA).