Web Content Management

WHITE PAPERS AND CASE STUDIES

• Measuring Laser Output In Medical Equipment Manufacturing For FDA Approval

  With expertise in power and energy measurement for lasers, see why Gentec-EO is the go-to choice for medical manufacturers in need of accurate and reliable laser beam measurement solutions.

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

• Partner Case Study: Accelerating Gene Editing Manufacturing

  Beam Therapeutics partnered with ElevateBio to manufacture BEAM-101, a novel base editing therapy for sickle cell disease, advancing rapid, high-quality production towards clinical trials.

• Mobilizing Compliance: USP 797 And 800 Pharmacy Trailer Fleet For VA Hospitals

  VA hospitals across the US are undergoing renovations to bring their facilities into compliance. The challenge was to design and manufacture a fleet of self-sufficient mobile compounding pharmacies.

• Rescuing A Global Full-Service Phase III Trial For A Late-Stage Oncology Biotech

  This case underscores the expertise employed in a comprehensive strategy and set of services that were used to salvage a Phase III clinical trial for ovarian cancer and ensure its timely completion.

• Newport News, VA Deploys 130,000 Mueller AMI Meters

  Eight years ago, Newport News started having discussions about moving away from reading their mechanical, manually read meters every other month to go to monthly billing. Knowing they did not have adequate staffing to handle that task, the department decided to outsource its meter reading responsibilities to a third party. 

• eCOA: Unified Approach Streamlines Processes, Speeds Start Up And Improves Data Quality

  Discover how a leading biopharmaceutical company revolutionized its clinical development with an eCOA solution that optimized its processes, cut build times, and enhanced data quality.

• Examining A Phase 1 COVID-19 Clinical Trial

  Uncover how we were able to efficiently activate the site and enroll 130 participants within six months, demonstrating our expertise in clinical trial management.

• Expanding Diabetes-Related Eye Health Equity

  20/20 Onsite, American Diabetes Association and Genentech collaborated on an event to provide immediate diagnostic services, including retinal imaging and visual acuity assessments, directly on-site.

• Accelerating Cold Chain Expansion: Responding To COVID-19 Challenges

  Review how leveraging cross-functional teamwork helped complete a cold chain infrastructure expansion in a fraction of the expected timeline, ensuring the production of essential COVID-19 therapeutics.

• Building A High-Quality IND From Scratch With Strategic Gap Analysis

  A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

• Custom Orthodontic Aligner Manufacturer Ensures Compliance With Tulip

  A pioneering orthodontic startup is transforming custom aligner production using 3D printing and software to cut time and costs in half while scaling rapidly to ensure quality and compliance.