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Horizon Lines: A Quarterly Review of NDAs – October- December 2025
This quarterly review of New Drug Applications contains data for applications approved for the first time during the last quarter of 2025, which includes New Molecular Entities (NMEs) and new biologics. A total of 40 applications were approved by the FDA during these three months. read more
Should Sponsors Provide Source Document Templates?
Sponsor-provided templates provide a compelling opportunity to improve upstream trial execution. However, in today’s world of increasingly complex and data-driven trials, the opportunity comes with important caveats. read more
Material-Sparing Strategies for Rapid Development and Scale-Up of Complex Drug Products
In an industry where complex molecules and first-in-human (FIH) formulations often come with very limited API supply, material-sparing strategies are central to efficient CMC development. read more
How AI is Transforming Clinical Trials
AI is already reshaping the clinical trials industry and that transformation looks set to continue over the next five years. New technologies will enable the development of more personalized medicines, empower more responsive trial designs and improve informed decision making by unlocking new data insights. read more

Clinical Trials - Transforming Drug Development
Transforming Drug Development: Accelerating Clinical Trials through Patient-Centric Innovations and Technological Breakthroughs Watch Now

Minaris Enhances GMP Cell Banking Suites at Philadelphia Facility
Thursday, June 18, 2026
Minaris announced the enhancement of its dedicated GMP cell banking suites at its Philadelphia facility, a centralized hub for cell banking and ... read more
Alcami Expands Quality, Packaging, and Storage Capabilities at Tennessee Facility
Thursday, June 18, 2026
Alcami Corporation announced a series of strategic and operational investments at its Tennessee facility, which was recently added to the company’s ... read more
WuXi Biologics' Suzhou Biosafety Testing Center Receives Fourth EMA GMP Certification
Thursday, June 18, 2026
WuXi Biologics announced that its Biosafety Testing Center in Suzhou has successfully passed a Good Manufacturing Practice (GMP) inspection by the ... read more
Mabion Reactivates MabionCD20 Through Rare Disease Collaboration with Oddifact
Thursday, June 18, 2026
Mabion S.A., a Polish biotechnology company, has signed a letter of intent (LoI) with French TechDev company Oddifact SAS to evaluate and advance ... read more
Neuland to Open $20M Dedicated Process Development Facility with Integrated Kilo Labs in Hyderabad
Tuesday, June 16, 2026
Neuland Laboratories will open a dedicated process development laboratory and integrated kilo lab at its Genome Valley campus in Hyderabad. read more