In January 2025, the US FDA published a draft regulatory guidance entitled “The Considerations for Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products”.
The regulatory guidance aimed at formulating a risk-based credibility assessment framework to examine the usefulness of AI models in decision-making about the safety and efficacy of drugs and biological products. The 2025 guidelines also emphasize transparency, data quality, and continuous monitoring.
From February 2, 2025, pharmaceutical companies in the European Union (EU) region must comply with AI literacy requirements and avoid AI practices that are prohibited under Article 514. By August 2, 2025, obligations for general-purpose AI models will take effect, which might impact AI-driven drug development and regulatory submissions.8
Corporate Sustainability Reporting Directive (CSRD), an EU directive mandate effective from 2025, requires pharmaceutical companies to disclose environmental, social, and governance (ESG) activities to strengthen transparency in sustainability efforts.
The Digital Operational Resilience Act (DORA) is an EU regulation, effective from January 17, 2025, that focuses on ensuring a secure financial system in Europe.
DORA ensures strong cybersecurity resilience measures for financial entities for higher transparency in financial transactions and supply chain financing in pharmaceutical companies.
The FDA encourages pharmaceutical companies to adopt advanced manufacturing technologies (AMTs) to improve the reliability and robustness of the manufacturing process.
AMTs would be significantly beneficial because they could reduce drug development time and enhance product quality.
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.
Dibutyl sulfide is an organosulfur. It is a clear, colorless to pale yellow liquid characterized by a strong sulfur-like odor and is primarily used as an intermediate in chemical synthesis, specialty organic manufacturing, and research applications. The compound exhibits good solvency properties and moderate thermal stability, making it useful in industrial and laboratory processes involving sulfur-containing organic compounds.
Oleylamine is a long-chain (C18) primary fatty amine derived from natural fatty acids, typically sourced from vegetable oils. It is produced from oleic acid through conversion of the carboxylic acid group (–COOH) into an amine group (–NH₂). With its optimal balance of hydrophobic chain length and reactive amine functionality it serves as a versatile and dependable building block for high-performance formulations.
Sodium Hyaluronate is the sodium salt of hyaluronic acid, a naturally occurring glycosaminoglycan known for its exceptional ability to retain moisture, along with its viscoelastic and biocompatible properties, making it highly valuable across pharmaceutical, cosmetic, and biomedical applications.