Nitrosamine USFDA Guidelines: Managing NDMA Contaminants in Human Medications
Nitrosamine USFDA Guidelines: Managing Nitrosamine Contaminants in Human Medications Nitrosamine Earlier today (September 4, 2024), the Center for Drug Evaluation…
Regulatory Pharma Blogs
Nitrosamine USFDA Guidelines: Managing Nitrosamine Contaminants in Human Medications Nitrosamine Earlier today (September 4, 2024), the Center for Drug Evaluation…
SAHPRA South Africa: eCTD Compliance and Technical Review for Renewal Applications – Template SAHPRA South Africa The South African Health…
What is Good Laboratory Practice (GLP) Good Laboratory Practice (GLP): The Principles of Good Laboratory Practice (GLP) set forth guidelines…
What is stability testing of new drug substances and products Stability testing of new drug substances and products the purpose…
ASEAN common technical dossier (ACTD) for the registration of pharmaceuticals for human use: ASEAN Common Technical Dossier (ACTD) serves as…
Procedure for export of Indian drug product in overseas market Procedure for export of pharmaceutical products Background pharmaceutical Procedure for…
Overview of Regulatory authorities and agencies of (Organization structure and types of applications): India United States European Union Australia Japan…
Regulatory Approval Process for Investigational New Drug (NDA-24) Investigational New Drug Background Investigational New Drug Investigational New Drug The drug…
New Drug Discovery and developments-Pharmaceutical regulatory affairs-2024 New Drug Discovery and developments Drug discovery is a complex and multi-step process…
Clarios SpiroSphere® with wireless ECG- FDA clears, simplifying clinical trial data collection. Clarios SpiroSphere The FDA has granted 510(k) clearance…