07.16.25 -- The FDA Was Darned Near Perfect, Right?

Biotech companies racing toward IND submissions must prioritize strong project management when selecting a CDMO. Breakdowns in communication, visibility, and consistency, especially during key handovers, can divert internal focus away from science. Effective project management isn't optional—it’s the strategic backbone of successful CDMO partnership. Read the full article.

Discover how the capabilities of a CDMO bring forth innovative, flexible solutions to safeguard supply chains for their clients and, ultimately, for their patients.

From fully developed large-scale manufacturing and packaging to a single development batch, a contract services organization must be prepared to handle multiple compounds in the same facility.

Explore a comprehensive overview of the challenges, requirements, and best practices for safely working with compounds in drug development and manufacturing.

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

Whether you aim to address bottlenecks or explore advanced techniques, gain a practical and forward-thinking perspective to streamline early-phase development with HTE and model-based approaches.

Learn how CDMOs can drive transformation in the supply chain and create a more sustainable future for the pharmaceutical manufacturing industry.

Observe as David Lyon, Ph.D., and Molly Adam answer attendee questions from a recent webinar about three enabling technologies designed to improve drug solubility in organic solvents for spray drying.

Ensure safe and effective development of highly potent therapies with our proven expertise, specialized facilities, and robust containment systems designed to support every drug development stage.

Review as President of Snapdragon Chemistry, Matthew Bio, Ph.D., presents the company’s capabilities in the development of peptide therapeutics.

We have defined work flows to assess and select solid forms in a cost and time efficient manner that meets the needs of each individual program.