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Innovative Strategies to Accelerate Drug R&D, and Regulatory Approvals Saher Haider
October 15, 2024
Global health crises, with the COVID-19 pandemic being the most predominant one, revealed the importance and the stark inefficiencies of traditional drug development pathways.
Simplifying Regulatory Submissions with e-CTD and Digital Dossier Management Saher Haider
August 02, 2024
Employing e-CTD and digital dossier management systems will not only support faster submission processes but also improve the accuracy and reliability of the data presented to regulators.
The Regulatory Effects of Natural Products on Intestinal Flora Xiaomichong
June 25, 2024
The intestinal flora is an important component of the intestinal microecosystem, and humans have formed a mutually beneficial symbiotic relationship with the intestinal flora during the long process of evolution.
New Research Launched at BIO24 Finds CROs with In-house Regulatory Affairs Can Deliver 30% Savings, Halve Timelines and Cut Risks for Biotechs PharmaSources
June 05, 2024
New research showes that biotechs can save more than 30% in costs, halve start-up times, and cut risk with CROs that have in-house scientific and regulatory affairs.
Regulatory guidelines for Electronic Batch Record Muhammad Asim Niazi
April 12, 2024
Electronic Batch Record is a software system or a set of digital tools that automatically updates the batch record as the production progresses on the production floor.
Continuous Manufacturing Part 1: Changes in Global Regulatory Landscape Deepak Hegde
February 05, 2024
It's been about three years since I had written the three-part series of articles on Continuous Manufacturing (CM). Since then, a lot of water has flown under the bridge and there have been several developments in the field of CM. Now is probably the righ
Regulatory Compliance in API Drug Production of Different Countries PharmaSources
January 02, 2024
Active pharmaceutical ingredients, also known as APIs, refer to the biologically active components of drugs that provide pharmacological activity or direct action.
New regulations in the Year 2023 for different regulatory bodies around the world Muhammad Asim Niazi
January 23, 2024
This article will explore new regulations in countries like the United States, Europe, Japan, and Australia.
The drug regulatory landscape in China: Progress and Reform Deborah Seah
April 20, 2023
Since 2015 when drug approval policies and process have begun its reform, China has seen improvements in both the speed and predictability of drug approvals over the past few years.
Why Drug regulatory authority updates their Rules and Regulations Muhammad Asim Niazi
March 21, 2023
Pharmaceutical regulatory authorities regularly update their rules and regulations regarding drug review and approval.