Introduction of DMF/CEP :The Importance of Regulatory Submissions Introduction to DMF/CEP Introduction to DMF/CEP A Drug Master File (DMF) and Certificate of Suitability (CEP) are crucial documents in the pharmaceutical industry, ensuring the quality...
Skin Products: Quality and Similarity of Topically Applied, Locally Acting Skin Products Skin Products: The European Medicines Agency (EMA) has recently revised its guideline on Quality and Equivalence of Topically Applied, Locally Acting Skin...
What is in-vitro-in vivo correlation (IVIVC) In-vitro-in vivo correlation (IVIVC) is a mathematical model that predicts the connection between an in vitro characteristic of a drug formulation and its corresponding in vivo effect. In...
Analytical Methods Validation for Quality Assurance and Process Validation Experts Abstract:Analytical Methods Validation Analytical Method validation is a fundamental process in the pharmaceutical industry, essential for ensuring that analytical procedures used in testing are...
USFDA Guidance: Incorporating Voluntary Patient Preference Information Throughout the Product Life Cycle The USFDA Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) have issued a draft...
News Articles / Pharmaceutical engineering
by samitfm · Published August 9, 2024 · Last modified December 30, 2024
Research and Development in the Pharmaceutical Industry Research and development in the pharmaceutical industry is an intricate and exciting path from idea to implementation. It’s the intersection of science and innovation, leading to significant...
News Articles / Pharmaceutical engineering
by samitfm · Published August 7, 2024 · Last modified January 8, 2025
3D Printing technology in Pharmaceuticals 3D Printing technology in Pharmaceuticals: Additive manufacturing, commonly known as 3D printing, is making significant strides in the pharmaceutical sector. This innovative technology allows for the creation of complex...
News Articles / Regulatory affairs
by samitfm · Published August 6, 2024 · Last modified January 8, 2025
What is Good Laboratory Practice (GLP) Good Laboratory Practice (GLP): The Principles of Good Laboratory Practice (GLP) set forth guidelines and standards for a quality system that manages the processes and conditions involved in...
Akums Drugs and Pharma shares surge by 7% after listing. Should you buy, sell, or hold? Akums Drugs Shares Akums Drugs Shares of Akum Drugs & Pharmaceuticals had a subdued debut on Dalal Street...
Regulatory Concepts Basic terminology,Guidelines, Regulations Regulatory Concepts Investigational Product Guidelines, Regulations Regulatory Concepts A newly developed medication created by a manufacturer.Basic terminology Phase III Clinical Study A randomized trial conducted by the manufacturer to...
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