What is a DUNS Number and Why Does Your Business Need One?
Credibility and transparency are the secrets of success in the contemporary business environment that is characterized by global interconnectedness. Among the key instruments that contribute to the creation of both is a DUNS Number. In Masuu Global, we have realized the significance that businesses both large and small should have their presence felt internationally.
Nitrosamine Impurity Risk Assessment: Ensuring Product Safety and Regulatory Compliance
The use of nitrosamines in pharmaceutical manufacturing has become a major topic of interest because it is considered a probable carcinogen in humans. All regulators, such as the FDA and EMA, are currently mandating manufacturers to evaluate and mitigate the risk of nitrosamine impurities in both finished drug products and active pharmaceutical ingredients (APIs).
What is an Investigational Medicinal Product Dossier (IMPD)? A Guide to the Investigational Medicinal Product Dossier
Regulatory documentation is crucial in ensuring safety and effectiveness of the new medicines in the complicated world of drug development and clinical research. The IMPD, or the Investigational Medicinal Product Dossier is one of those key documents in the European clinical trial system.
Pharmaceutical industries require their products to be able to promote drug safety during the lifecycle of such products. The Pharmacovigilance System Master File (PSMF) is one of the most important documents in favor of this endeavor in the European Union (EU) and other areas. So, what is a PSMF and why is this so essential to regulatory compliance?
What is an Active Substance Master File (ASMF) Submission and Why It Matters in Pharmaceutical Regulatory Strategy
The pharmaceutical industry is a highly regulated sector where the quality, safety and efficacy of a drug product is highly reliant on the quality of its components-most predominantly the active pharmaceutical ingredient (API). The Active Substance Master File (ASMF) is one of the most important means of helping to promote this integrity, as well as safeguarding proprietary information.