Qualtiy Assurance

WHITE PAPERS AND CASE STUDIES

• Optimizing Kitting For Cell Therapy Trials In Pediatric Oncology

  Precision for Medicine’s Kitting team played a crucial role in overcoming this challenges of a Phase I multicenter pediatric cell therapy trial targeting relapsed or refractory solid tumors.

• What Changes When Your CPV Goes Digital

  Explore the advantages of digitalizing Continued Process Verification (CPV) through the experience of a pharmaceutical company step-by-step.

• Regulatory Affairs Project Manager

  Discover how a ProPharma consultant effectively integrated tools, streamlined processes, and enhanced communications within a biotech company to ensure regulatory filings would be delivered promptly and with the highest level of quality.

• Disinfection Of Acid Wastewater Discharge In Taiwan

  A leading semiconductor foundry in Taiwan, internationally renowned for its advanced manufacturing technology and continuous innovation, needed to treat Acid Wastewater Discharge (AWD) in its backend discharge system.

• BioIVT Collaborates With IDBS To Deploy IDBS E-WorkBook And Reduce Study Cycle Times

  Learn about a collaboration that has enabled BioIVT to enhance efficiency and responsiveness to its biopharmaceutical clients.

• Symmetry Surgical Uses Software To Enhance Quality

  Symmetry Surgical enhances operations and quality management using software to improve efficiency, compliance, and data-driven decisions while producing over 2 million surgical devices annually.

• Breaking Barriers In Malaria Prevention With A Mobile Cleanroom

  The delivery of this mobile cGMP cleanroom facility to ACT showcases Germfree’s commitment to providing innovative solutions that meet clients' unique needs and contribute to advancing healthcare.

• Data Matters: Accelerating Dermatology Research With Precision!

  When deadlines are tight, execution matters. Find out how Palleos delivered critical data packages, statistical analysis, and regulatory-ready documentation—on time and with precision!

• How Sharp Packaging's Clinical Packaging Process Is 30% Faster

  Discover how digitized workflows and real-time verification are helping streamline clinical trial packaging, reduce complexity, and improve quality in a high-stakes, time-sensitive environment.

• GMP Manufacturing Cycle Time Reduction

  Identifying process redundancies and enhancing visual management allows manufacturers to stabilize workflows. These data-driven improvements can decrease operational variability by nearly 50%.

• Coordinating Global Capabilities To Support A Gene Therapy Targeting A Rare Neurodegenerative Disorder

  Advance your gene therapy program with expert support for IND submission, including GLP toxicology, biodistribution studies, and tailored CMC services.

• Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines

  As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.