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.
New Drug Application (NDA) Submission: Your Path to U.S. Market Approval
Marketing a product through pharmaceutical science is a major scientific and regulatory accomplishment. The NDA is the regulated pathway by which small-molecule drug developers can endeavor to obtain the authorization to market their products (via marketing approval by the United States FDA). We at Masuu Global have been able to assist and guide the process of sponsoring the NDA submission process by offering clarity, compliance, and strategic precision to the sponsor.
