This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.
- On The Potency Assurance Journey, Travelers Need A Road Map
- Guidelines For Defining A Control Strategy Framework For Accelerated mAb Programs
- A Multi-Omics Approach For Characterizing Clinical-Scale iPSC Batches
- Global Implications Of Zero Tariffs On Indian Pharma Exports To China
- Why Do So Few Cell Therapies Make The Leap From Lab To GMP?
- Process Validation: Working Toward Harmonization Of Terms Used To Identify Validation Lots
- Careful Outsourcing Proves Key To Targeted Protein Degradation Drug Development
- What Can The Tech Sector's 'Minimally Viable' Concept Teach Biopharma?
ON-DEMAND WEBINARS
Explore the opportunities to optimize your supply chain strategy and facilitate direct-to-site, direct-to-patient and hybrid services utilizing a global GMP depot network.
CGT pioneers require supply chain partnerships that mitigate trial risk and complexity. Explore how to optimize pre-trial and pre-screening activities and reduce trial cost and risk with an IRT solution.
The COVID-19 global pandemic took the world by storm, disrupting several industries and our global supply chains. Learn why having a contingency plan and proactively planning gives a company a competitive edge.
With so many moving parts in a clinical trial, why worry about the technology that is supposed to help manage it? In this webinar, explore five actionable and necessary strategies to leverage RTSM to simplify clinical trial operations.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![GettyImages-184945838-cold-chain-cryopreservation]( "Prepping For Commercialization Through Supply Chain Logistics")
Prepping For Commercialization Through Supply Chain LogisticsWhile cell and gene therapies are bringing new hope to patients experiencing rare and serious diseases, uncover how they're disrupting the biopharma market in new and challenging ways.
-
![iStock-1277730987-supply-chain-logistics-tracking-sourcing]( "Planning For The Return And Destruction Of Your Product")
Planning For The Return And Destruction Of Your ProductAspects of accountability, reconciliation, return, and destruction require significant effort to compile historical data. A little up-front planning can remove many future complications.
-
![Trial Design]( "When Protocol Amendments Meet RTSM: From Headache To High-Performance")
When Protocol Amendments Meet RTSM: From Headache To High-PerformanceLearn why an RTSM solution should be adaptive and flexible, and should help clinical trial teams uncover the best ways to handle protocol amendments.
-
![BCS2024-1341-05MAY---IQVIA-IRT-Clinical-Trials-Arena-Award-THUMB]( "Streamlining Clinical Supply With Advanced Automation")
Streamlining Clinical Supply With Advanced AutomationClinical trials are the backbone of pharmaceutical advancements, but they come with their own set of challenges, particularly in data management and supply chain logistics.
-
![iStock-635767756-clinical-trial-research]( "Building A Flexible, Challenge Resistant, Patient-Centric Clinical Supply Chain")
Building A Flexible, Challenge Resistant, Patient-Centric Clinical Supply ChainFlexible solutions, like demand-led supply and direct-to-patient distribution, are helping sponsors address the growing list of challenges presented by today’s increasingly complex studies.
-
![GettyImages-980809416 clinical supply]( "Common RTSM/IRT AN Medication Pooling Questions Answered")
Common RTSM/IRT AN Medication Pooling Questions AnsweredWhether you’re planning a single trial or an entire program, medication pooling offers a pathway to cost-effective and sustainable clinical trial management.
-
![iStock-1293772969-lab-microscope-scientist-research]( "Clinical Manufacturing: What It Is And How It Works")
Clinical Manufacturing: What It Is And How It WorksClinical manufacturing is a specialized form of pharmaceutical manufacturing focused on producing drugs for clinical research. How does it work and how is it different from commercial manufacturing?
-
![Singota]( "Faster From Formulation To Fill/Finish")
Faster From Formulation To Fill/FinishOptimize your speed to clinic by securing a development and aseptic fill/finish partner to support your applications with the right manufacturing equipment, communications, and SOPs.
-
![Pharmaceutical packaging pharmacy iStock-840095386]( "3 IRT Tactics Being Used To Streamline Supply Logistics")
3 IRT Tactics Being Used To Streamline Supply LogisticsShipping and storing leading-edge therapeutics require complex logistics, but enhanced automation and process simplification ensure that sites and patients have the drugs they need when they need them.
-
![Panademic Related Manufacturing Complications]( "Outsourcers Are Feeling Uneasy About Continuity Of Supply")
Outsourcers Are Feeling Uneasy About Continuity Of SupplyFind out how COVID-19 complications have picked up from the first year, with more outsourcers experiencing bigger obstacles when it comes to manufacturing, specifically with drug product.
CATALENT CORNER
| Insights from Catalent's Clinical Supply Experts |
SPONSORED CONTENT
Impact Of Supplier Choice On APAC Clinical Trial Execution
Learn about strategies Asia-Pacific has become an increasingly complex and congested destination for clinical trials as local and global sponsors alike flock to the region to take advantage of its many benefits, including access to large patient pools. Choosing the right clinical packaging and supply chain partner to support these studies is critical and can vary significantly based upon what countries are involved and the types of services required.
