Newsletter | May 1, 2026

05.01.26 -- The Quiet Case For Trusting CDMO Pricing

INDUSTRY INSIGHTS

Navigating The New USP Chapter <382> For Elastomeric Closures

Dive into the scope of <382> for pharmaceutical closures and the regulatory landscape, which includes new required tests, instrumentation for compliance, and recommendations on implementation.

Why Phase I Success Starts Long Before The Clinic

By integrating scientific rigor, regulatory foresight, and market awareness into early-stage planning, companies can leverage a robust TPP to optimize decision-making and development.

Quality First: Why CDMO Excellence Ultimately Depends On Trust

Operational excellence relies on strong quality foundations that sustain speed and flexibility. Rigorous standards reduce risk, accelerate progress, and build the trust needed for lasting success.

FEATURED EDITORIAL

The Quiet Case For Trusting CDMO Pricing

“Given our industry, with so much forward risk, my overall philosophy is not to necessarily get stuck on pricing," says a commercially successful outsourcing veteran, although he quickly adds, “I don’t broadcast this externally, or even internally – quote me anonymously!" I did, and he proceeded to provide intriguing insight into working with CDMOs.

FDA's First cGMP Enforcement Action On AI Misuse In Drug Manufacturing

The warning letter, issued to Purolea Cosmetics Lab, describes a manufacturer that used AI agents to generate drug product specifications and more. Here's why the outsourced pharma industry should take note.

INDUSTRY INSIGHTS CONTINUED

A Roadmap To Expedited Review Pathways

Accelerated development and manufacturing timelines provide developers with paths to move new therapies to market quickly while still maintaining a balance of risk/benefit assessment. 

How A Specialized CDMO De-Risks Complex API Development

Rising API complexity and AI-driven chemistry require specialized CDMOs with technical expertise in hazardous or chiral synthesis to successfully navigate the transition to GMP manufacturing.

Powering Drug Development With Advanced AI Retrosynthetic Analysis Tools

Review advanced retrosynthetic analysis services and how these tools empower better, more efficient development of innovative small molecule drugs.

SOLUTIONS

Flexible Pharmaceutical Tablet Manufacturing Solutions

Multiparticulates For Modified Release Systems

Strengthening The Small‑Molecule Supply Chain

Our Small Molecule Development And Manufacturing Experience

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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