News Articles / Regulatory affairs
by samitfm · Published April 24, 2024 · Last modified January 10, 2025
Difference between ACTD and CTD, eCTD Regulatory affair Dossier preparation eCTD Regulatory Overview The electronic Common Technical Document (eCTD) is an electronic submission format for regulatory documents that is widely used in the pharmaceutical...
Clinical Research / News Articles
by samitfm · Published April 22, 2024 · Last modified January 10, 2025
Navigate Liabilities in Clinical Research Navigate Liabilities Clinical research is a high-risk activityLiability cannot be waived Control Risk & Liability Navigate Liabilities Liability can not be waived but risk can be controlled.This ethical responsibility...
Clinical Research / News Articles
by samitfm · Published April 16, 2024 · Last modified January 10, 2025
Development of clinical trials information system CTIS Development Development of clinical trials information system Development of clinical trials information system Clinical trials are essential for the development of new medical treatments, therapies, and procedures...
Medical Devices / News Articles
by samitfm · Published April 16, 2024 · Last modified December 30, 2024
Risk management for medical device and pharmaceuticals Risk management, to guarantee the security and effectiveness of medical equipment and prescription drugs, risk management is an essential procedure. We will provide a thorough rundown of...
Clinical Research / News Articles
by samitfm · Published April 16, 2024 · Last modified January 10, 2025
Bioequivalence Trial Information -SAHPRA GENERAL INSTRUCTIONS: Bioequivalence Trial Information Please review all the instructions thoroughly and carefully prior to completing the Bioequivalence Trial Information Form (BTIF). Provide as much detailed, accurate and final information as...
Clinical Research / News Articles
by samitfm · Published April 16, 2024 · Last modified January 9, 2025
Clinical data management (CDM) Clinical data management (CDM) consists of various activities involving the handling of data or information that is outlined in the protocol to be collected/analyzed. CDM is a multidisciplinary activity. Introduction ...
News Articles / SAS / Software Excels
by samitfm · Published April 15, 2024 · Last modified January 9, 2025
Free Pharmacokinetic Software & Excels used in PK/PD analysis-10+ What is PK/PD Analysis Free Pharmacokinetic Software & Excels used in PK/PD analysis is pharmacokinetics (PK) refers to the process of how drugs move within...
News Articles / Regulatory affairs
by samitfm · Published April 8, 2024 · Last modified January 9, 2025
USFDA Guideline for : Clinical Investigations of Medical Products Involving Children USFDA Guideline on September 23, 2022, the US Food and Drug Administration issued a preliminary guidance concerning the ethical aspects of involving and...
News Articles / Regulatory affairs
by samitfm · Published April 8, 2024 · Last modified January 9, 2025
Submitting data in the NeeS format – TGA -Australia The following guidance is intended for sponsors and manufacturers interested in providing data in the NeeS format for various types of products, including prescription medicines,...
News Articles / Regulatory affairs
by samitfm · Published April 5, 2024 · Last modified January 9, 2025
Tech Innovations Exploring New Directn in Regulatory Affairs 2024 Tech Innovations on a global scale, the Life Sciences and Pharmaceutical sector continually integrates advanced technologies and innovative therapies to enhance the quality of medicines,...
Follow:
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.
Zaims Pharma’s content is for informational and educational purposes only. Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment.
More
Recent Comments