Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

FDA Letters Made Public Are Creating New Risks

There is a pharma-backed citizen petition challenging the FDA over its new practice of publicly releasing redacted Complete Response Letters (CRLs). It could potentially end in a lawsuit. Chief Editor Louis Garguilo provides early analysis of what is at stake.

GUEST COLUMNISTS

Validating Candel's BLA-Ready Analytics Profile
The adenovirus/prodrug company discusses in-house assay development and the validation work to confirm CQAs like potency and cell line integrity.
Mapping Candel Therapeutics' Sprint To The BLA Finish Line
Leaders from the adenovirus/prodrug developer discuss the complex balancing act of preparing to scale up for commercial manufacturing without overextension.
The Hidden Operational Cost Contained In Every Small Molecule Portfolio
The volume of post-approval changes is rising and the manual approaches that have worked until now are no longer adequate. Get ahead of this to spend less and execute faster.
Field Notes: APEC RHSC's Workshop On ATMP Development And Evaluation
Scientific and regulatory leaders in the Asia-Pacific region met recently for an exchange of strategies to strengthen convergence and technical competence.
U.S. Pharma Tariffs And MFN Become Law After April 2 Update
Beginning July 31, 2026, a U.S. pharmaceutical tariff will apply to patented products and their APIs, beginning with large companies. Beroe Inc.'s Mathini Ilancheran breaks down the tariff's impact, explores its risks, and proposes five procurement strategies to addressing them.
How To Implement Post-Approval Changes On A Global Level
To prepare for inevitable process changes after market authorization, this overview provides critical planning advice for assessing risk and minimizing delays.
March 2026 — CDMO Opportunities And Threats Report
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.
The Business Case For Continuous Manufacturing In Biologics
The question for leadership is not if continuous manufacturing will transform biologics, but when and how quickly to invest.

PHARMA OUTSOURCING WHITE PAPERS

EMA Support For Rare Disease Therapies
Review how the EMA supports rare disease drug development through regulatory and financial incentives for therapies that meet strict eligibility and ongoing compliance criteria.

Safety, Containment, And Analysis Of Highly Potent Compounds
Explore a comprehensive overview of the challenges, requirements, and best practices for safely working with highly potent compounds in drug development and manufacturing.
Modernizing Clinical Trial Logistics To Deliver Value
Explore how biopharma organizations can design and operate clinical supply systems that absorb complexity while maintaining control and consistency.
Quality By Design (QbD) For Biologics From A CDMO Perspective
Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.
A Decade Of Transforming Pharmaceutical Manufacturing
Modern enzyme engineering, automation, and AI are reshaping therapeutic development — accelerating design, improving efficiency, and enabling faster, more sustainable biopharma manufacturing.
Redefining The Analytical Frameworks Surrounding Capsid Characterization
Modern AAV manufacturing demands precise capsid characterization to distinguish empty, partial, and full particles, as regulators now require rigorous purity and potency control for clinical safety.