Software Development: Regulatory affair Compliance in Software Development requirements Software development In the complex world of regulatory affairs, having the right tools and software is essential for driving efficiency and ensuring compliance. These specialized...
Information about Nitrosamine Impurities 2024 in API and finished pharmaceutical products Nitrosamine Impurities: The FDA has released a revised guidance titled “Control of Nitrosamine Impurities in Human Drugs,” which outlines the agency’s updated approach...
Regulatory affairs / Software Excels
by samitfm · Published December 6, 2024 · Last modified January 8, 2025
Regulatory Submission Software:Ultimate Guide in the Pharmaceuticals Introduction to Regulatory Submission Software Regulatory Submission Software: In the highly regulated life sciences sector, regulatory submission software has become an essential tool for companies aiming to...
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...
Analysis of Particle Size Distribution D10/D50/D90 Analysis particle size distribution is crucial for quality control and research, as it directly impacts various material properties. These properties include flow characteristics, reactivity, abrasiveness, solubility, extraction efficiency,...
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...
Clinical Research / Regulatory affairs
by samitfm · Published September 28, 2024 · Last modified December 26, 2024
Data Requirements for Step 2: Preclinical Studies Preclinical Studies 7.1 Prerequisites for Conducting Preclinical Studies Preclinical studies Before initiating preclinical studies, the applicant must adhere to RCGM guidelines, which include demonstrating the consistency of...
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...
Biologics Similar: Principles for Development of Biologics Similar Biologics Similar biologics are created through a systematic process aimed at demonstrating their similarity to a reference biologic by conducting thorough characterization studies of molecular and...
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...
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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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