News Articles / Regulatory affairs
by samitfm · Published July 8, 2024 · Last modified January 8, 2025
What is stability testing of new drug substances and products Stability testing of new drug substances and products the purpose of this communication is to detail the updates incorporated in Q1A(R) following the adoption...
ASEAN common technical dossier (ACTD) for the registration of pharmaceuticals for human use: ASEAN Common Technical Dossier (ACTD) serves as a standardized framework for preparing comprehensive applications intended for the registration of pharmaceuticals and...
News Articles / Regulatory affairs
by samitfm · Published July 3, 2024 · Last modified January 8, 2025
Procedure for export of Indian drug product in overseas market Procedure for export of pharmaceutical products Background pharmaceutical Procedure for export of pharmaceutical Indian drug product in overseas market India holds a prominent position...
News Articles / Regulatory affairs
by samitfm · Published July 2, 2024 · Last modified January 8, 2025
Overview of Regulatory authorities and agencies of (Organization structure and types of applications): India United States European Union Australia Japan Canada Background Regulatory authorities and agencies Regulatory affairs in the pharmaceutical industry focus on...
News Articles / Regulatory affairs
by samitfm · Published June 29, 2024 · Last modified January 8, 2025
Regulatory Approval Process for Investigational New Drug (NDA-24) Investigational New Drug Background Investigational New Drug Investigational New Drug The drug approval process involves a regulatory pathway through which individuals, organizations, sponsors, or innovators obtain...
New Drug Discovery and developments-Pharmaceutical regulatory affairs-2024 New Drug Discovery and developments Drug discovery is a complex and multi-step process that involves identifying chemical compounds for potential therapeutic use in treating and managing various...
Medical Devices / News Articles
by samitfm · Published June 14, 2024 · Last modified January 8, 2025
Clarios SpiroSphere® with wireless ECG- FDA clears, simplifying clinical trial data collection. Clarios SpiroSphere The FDA has granted 510(k) clearance for the COR-12 wireless ECG device, now seamlessly integrated with SpiroSphere®. This integration enables...
Medical Devices / News Articles
by samitfm · Published June 14, 2024 · Last modified January 8, 2025
DSCSA (Drug Supply Chain Security Act): FDA extends on 24 DSCSA tracking rules for small dispensers by two years and allows exemption requests. DSCSA (Drug Supply Chain Security Act): On Wednesday, the US Food...
Medical Devices / News Articles
by samitfm · Published June 12, 2024 · Last modified January 8, 2025
Medical device equipment: The report suggests strategies to enhance accessibility and cost-effectiveness of crucial medical device equipment. Medical device equipment Encouraging the local production of vital medical equipment, establishing a reliable logistics network and...
Device surveillance the European Unions Medical Device Coordination Group (MDCG) has released revised guidance on device surveillance. Device surveillance The Medical Device Coordination Group (MDCG) has recently issued an updated version of its Surveillance...
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At Zaims Pharma, we focus on the intersection of pharmaceutical regulations, compliance standards, and the transformative power of technology. Our team is passionate about simplifying the complexities of the industry, whether through in-depth articles, expert interviews, regulatory updates, or software solution reviews. We provide valuable tools and actionable insights that help our readers navigate the evolving landscape of pharmaceuticals and healthcare.
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