Newsletter | September 3, 2025

09.03.25 -- What FDA's Complete Response Letters (CRL) Say About Outsourcing

SPONSOR

Webinar: Liquid Phase Peptide Synthesis: Regulatory, Analytical & QC Perspectives

Discover how Cambrex is advancing peptide manufacturing with innovative liquid phase peptide synthesis (LPPS) technology, reducing costs, environmental impact, and reliance on specialized reactors. Join experts Adrian Amador and David Wang for this live webinar exploring LPPS applications, regulatory considerations, impurity control, and analytical strategies. Register today to gain insights that can accelerate your peptide development programs. Click here to learn more.

INDUSTRY INSIGHTS

Continuous Manufacturing: An Evolving Technology For Drug Manufacturing

Explore the exciting developments in continuous manufacturing, and learn how leveraging technology can help improve manufacturing processes and discover new clinical candidates.

Driving Precision, Agility, And Partnership In Complex Drug Development

Anshul Gupte Ph.D., RAC Drugs, VP of Pharmaceutical Development, shares about phase-appropriate development, technical hurdles, building agile teams, and planning strategy for novel therapies.

Increasing Bioavailability With Amorphous Solid Dosage Formulations

Discover the challenges associated with pH-dependent solubility for oral tyrosine kinase inhibitor drugs and how utilizing ASD formulation can help create more effective, patient-friendly drug products.

FEATURED EDITORIAL

What FDA's Complete Response Letters (CRL) Say About Outsourcing

Most readers know the FDA embraced "radical transparency” by publishing more than 200 complete response letters (CRLs) for drug and biologics applications submitted between 2020 and 2024. Hooray for the FDA; good for drug developers hard at work today.

Unlocking Value In Biopharma Operations: A C-Suite Call To Action

Operational readiness will separate the leaders from the laggards, whether you lead a pharma/biotech innovator, CDMO, or a combination of both.

INDUSTRY INSIGHTS CONTINUED

The High Requirements Placed On Pharmaceutical Labeling Solutions

Regulators are implementing new rules to combat counterfeit medicines. Learn how serialization, tamper-evident seals, and track-and-trace solutions protect products and patients from risk.

Blueprint To Modernizing CDMO Manufacturing Operations

Industry 4.0 is revolutionizing CDMOs and CMOs. Find out how AI, IIoT, and automation are driving smarter, faster, and more compliant manufacturing to ensure agility, precision, and innovation.

Technical Considerations For Selecting Softgels As An Oral Dosage Form

The unique characteristics of softgel capsules can play a pivotal role in the success of a drug. By addressing stability and shelf-life challenges, softgels have become a valuable tool for manufacturers.

Integrated Strategies for Achieving Regulatory Milestones Faster

See how an innovative formulation platform reduced development timelines and allowed a sponsor to find the optimal nafamostat formulation without adding unnecessary delays.

SOLUTIONS

Taste Masking And Customized Release Technologies For OSD Forms

Explore taste-masking solutions that can elevate your oral dosage forms, drive the success of your business, and address the needs of multiple, large patient populations.

Formulation Development: Science, Strategy, And Smarter Solutions

Navigate the complexities of pharmaceutical formulation when development is a high-stakes, precision-driven science, especially for early-phase injectable drugs.

Commercial Drug Sourcing For Clinical Trials

The right partner can leverage years of experience, market knowledge, industry relationships, and clinical packaging expertise to develop a sourcing strategy tailored to the needs of each study.

Best-In-Class Nanodevelopment Capabilities

A highly specialized team excels in creating unique nanoparticles for both small and large molecule APIs. Leveraging cutting-edge technology, they produce nanoformed materials as small as 10 nanometers.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. 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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