FEATURED EDITORIAL
Consultants tell Chief Editor Louis Garguilo that too often those who should know better – from executives to project managers – overestimate their ability to manage CMC activities.
That’s surprising, and suggests a fundamental - but detailed - refresher of the key positioning of CMC is in order as we approach yearend.
- The EU Overhauls Pharma Laws: What You Need To Know
- Non-Clinical Supply Needs More Outsourcing Strength
- September 2026 — CDMO Opportunities And Threats Report
- Your CDMO Quality Dashboard Is Green. What's It Hiding?
- An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?
- Escape The Biotech's Valley Of Death
- Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty
GUEST COLUMNISTS
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![September CDMO]( "September 2026 — CDMO Opportunities And Threats Report")
September 2026 — CDMO Opportunities And Threats ReportEach 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.
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![FDA-GettyImages-2271237562]( "An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?")
An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?
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![maritime trade protection, logistics cybersecurity, and global supply chain safety-GettyImages-2264675121]( "Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical Uncertainty")
Navigating Outsourced Pharmaceutical Testing Through Today's Geopolitical UncertaintyGeopolitical shocks are reshaping outsourced pharmaceutical testing. Learn how procurement teams can strengthen resilience and protect continuity.
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![Wave bioreactor set for Laboratory Reactor-GettyImages-1330740780]( "Is Your Supply Chain Ready For The End Of Class VI?")
Is Your Supply Chain Ready For The End Of Class VI?Revisions to USP <87> and <88> update biological reactivity testing — changes that are especially important for companies that rely on single-use technology.
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![GettyImages-1437342902]( "Beyond API Sourcing: Avoiding Supply Disruptions For Small Molecule Drugs")
Beyond API Sourcing: Avoiding Supply Disruptions For Small Molecule DrugsSupply resilience should be assessed across the complete drug product pathway rather than measured by the number of vendors listed in a procurement system.
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![futuristic virtual interface, data, charts graphs-GettyImages-2158826542]( "Why We Need Pharmaceutical Engineering Project Management As A Distinct Discipline")
Why We Need Pharmaceutical Engineering Project Management As A Distinct DisciplineApplying general project management to a regulated setting as a variant of PMP or PRINCE2 is one of the most consistent, and most avoidable, causes of cost overrun and delayed start-up.
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![FDA Headquarters MD-GettyImages-2278014569]( "Complete Response Letters For CGTs Share This Common Theme")
Complete Response Letters For CGTs Share This Common ThemeOne expert’s analysis found CMC-related concerns in about 75% of complete response letters. He outlines a path to stronger CMC readiness for cell and gene therapies.
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![DMAIC, Define, Measure, Analyze, Improve, Control-GettyImages-2103944843]( "Your 7 Decisions To Make Before MES Configuration")
Your 7 Decisions To Make Before MES ConfigurationDon't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.
PHARMA OUTSOURCING WHITE PAPERS
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![GettyImages-2179548801-ADC-3d-render]( "Advancing ADCs: From Concept To Commercialization")
Advancing ADCs: From Concept To CommercializationADC programs move fastest when payload-linker strategy, route design, conjugation, and drug product are planned together, with timelines and scale-up capacity shaping choices from the earliest development stages.
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![GettyImages-1297378718-contamination-gloves-suit-scientist-laboratory]( "Managing Risks With Potent Pharmaceutical Products")
Managing Risks With Potent Pharmaceutical ProductsManufacturing potent medications safely requires specialized containment, toxicology expertise, and strict contamination controls to ensure compliance, product quality, and worker safety.
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![iStock-459537393-pill-softgel-capsule]( "Is Your API Right For A Soft Gel Capsule?")
Is Your API Right For A Soft Gel Capsule?Soft gel delivery systems can enhance bioavailability, enable controlled release, support combination dosing, and handle potent compounds while improving stability and patient adherence.
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![scientist in lab discussing research-GettyImages-2194013442]( "Ensuring Business Continuity In Your Pharmaceutical Commercial Supply")
Ensuring Business Continuity In Your Pharmaceutical Commercial SupplyDrug shortages demand resilient supply chains and strategic partnerships. Learn how experienced manufacturers help mitigate risks and ensure reliable supply.
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![drug-production-small-mole-GettyImages-2278072672]( "10 Qualities Your CDMO Should Have For An Oral Dose Tech Transfer")
10 Qualities Your CDMO Should Have For An Oral Dose Tech TransferChoose a manufacturing partner that supports every development phase with regulatory expertise, supply chain resilience, and formulation know-how.
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![GettyImages-2183428951-biomanufacturing]( "Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities")
Biomanufacturing Readiness: A Validation Model For Multiproduct FacilitiesOptimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- Turning A "Brick Dust" Compound Into A Clinically Viable Oral Formulation
- Successful Tech Transfer Plans Ensured On-Time Launches
- Creating A New Dosage Form From An Approved Drug For A New Rare Disease
- Using Human-Centered Engineering To Improve HPLC Solvent Handling
- Supply Chain Diversification In Biopharmaceutical Manufacturing
REPORTING
NEW FOR OUR READERS
EDITORIAL COLLECTIONS
Take a closer look at the decisions shaping biopharma outsourcing. Our Editorial Collections examine how organizations select CDMOs, manage external relationships, transfer processes, and weigh the business realities of outsourced development and manufacturing.
More Editorial CollectionsPRODUCTS & SERVICES
ON-DEMAND WEBINARS
- Process Development For CGT: How Soon Is Too Soon?
- Pre-Developed Assays For Cell And Gene Therapies
- Unlocking Hidden Efficiencies In Cell And Gene Therapy Manufacturing
- Scaling Spray-dried Dispersions For Commercial Success: Scale, Capacity, Supply
- Bioconjugation Scale-Up: Data-Driven Strategies From 10 L To 500 L