The adoption of artificial intelligence (AI) and large language models (LLMs) is rapidly reshaping clinical research and drug development.
These advanced tools allow researchers to screen millions of compounds from chemical databases to identify promising therapeutic candidates, significantly reducing the time and cost typically required to explore the vast chemical space.
In clinical trials, AI models enhance the selection of patient populations and help predict outcomes, leading to higher success rates for novel drug development.
However, as AI becomes more embedded in the drug discovery pipeline, regulatory bodies have stepped up efforts to ensure these technologies are integrated safely and ethically. To that end, regulators are increasingly engaging with industry stakeholders to adapt and evolve policy frameworks.
Beyond AI, cloud-based technologies are pivotal in modernizing regulatory submissions and data exchange. Cloud platforms enable real-time collaboration and offer greater flexibility in product development and lifecycle management.
Despite these advantages, cloud-based systems also raise concerns about data security and intellectual property protection. These risks have prompted regulators to develop more stringent guidelines aimed at safeguarding sensitive information.
To support evidence-based decisions, regulatory agencies are also leveraging real-world evidence (RWE). Multiple studies suggest that incorporating RWE into regulatory evaluations has improved the overall quality of decisions on new drug approvals.
Standardization is another key focus area. Broader adoption of the electronic common technical document (eCTD) format within the International Council for Harmonisation (ICH) framework is helping bring greater consistency to regulatory submissions.
Standardized documentation not only reduces duplication and minimizes errors but also provides pharmaceutical companies with a more predictable and streamlined submission process.
Reference:
Regulatory Trends in Pharma Manufacturing: Key Changes to Watch in 2025
Today we announce that Exim is rebranding as ExSyn. We are presenting a new brand identity and website as a reflection of our relentless transformation over the course of 30 years serving the pharma and chemical industries. The new brand builds upon our core strengths as a sourcing company and captures our most essential duty: helping improve people’s health and lives.
Unleashing the Excitement with the Malina Casino App Table of Contents Introduction to Malina Casino Exploring the App Features Game Selection and Variety Safety and Security Measures Bonuses and Promotions Payment Options Available Customer Support and Assistance Conclusion Introduction to Malina Casino Welcome to the vibrant world of Malina Casino, a premier online gaming destination […]
The Vibrant World of Wazamba Casino Table of Contents Introduction to Wazamba Casino Games Offered Exciting Promotions Payment Methods Security and Fairness Customer Support Conclusion Introduction to Wazamba Casino Step into the exhilarating realm of wazamba casino, where adventure awaits at every turn! With its unique theme that immerses players in a colorful and vibrant […]
Peppermint (Mentha piperita) is a common herb, also known as a hybrid mint. Its main components are oxygenated monoterpenes: alcohols, esters and ketones. Peppermint oleoresin microencapsulated powder is a white to off-white coloured powder produced from the seeds of the plant. In order to protect and maintain the stability of peppermint oil, microencapsulation is carried out through process optimization using the coacervation technique. This technique helps limit the loss and degradation of flavours and aromas during processing and storage. It offers versatile applications across multiple industries — from food and beverages to pharmaceuticals, cosmetics, and textiles.