RFICs

WHITE PAPERS AND CASE STUDIES

• Expand Bandwidth With A Trusted Regulatory Writing Partner

  Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.

• Avoiding Unplanned Outages In Water Treatment

  Maintenance professionals within water and wastewater Treatment facilities are as busy as ever. To keep up with growing demands on their time, they are always looking for ways to improve the reliability and maintenance requirements within their scope of responsibility.

• Owen Mumford Slashes Audit Findings, CAPAs, And NCRs

  Gain insights into how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.

• Advanced Ozone Disinfection – City Of Fayetteville, Arkansas

  Discover how Fayetteville upgraded wastewater disinfection with advanced ozone technology, improving contaminant removal, reducing energy use, and delivering reliable, sustainable treatment for future regulatory demands.

• Cell Therapy Facility For DTM At NIH Clinical Center

  Discover how Germfree maximized available space and met cGMP cleanroom standards with a state-of-the-art modular cell therapy facility for the NIH, advancing treatments for serious medical conditions.

• A Pre-Clinical Study For Diet-Induced Obesity

  Here, we look at the importance of using high-fat diet-induced obesity models to evaluate and compare the efficacy of anti-obesity and anti-diabetic treatments like rimonabant and liraglutide.

• Successful EU MAA Submission Enabled By U.S.–EU Regulatory Collaboration

  Facing EU MAA complexity? Learn how one oncology sponsor met a fixed EMA deadline through global regulatory coordination, rapid dossier adaptation, and real-time submission execution.

• Driving A High-Adherence LTFU Trial Without An EDC

  Discover how our partnership with a client was able to deliver a ten-year long-term follow-up (LTFU) trial that delivered an over 90% adherence rate while keeping trial costs low by not using an EDC.

• Aseptic Expertise And Delivery Of Services

  A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.

• Bringing Clinical Testing To New Heights In New Jersey

  Explore how clinical testing was transformed with a pioneering BSL-2 mobile laboratory on a Sprinter Van platform to enhance safety and portability for advanced biosafety requirements.

• Challenging PFAS-Impacted Industrial Wastewater Reduced To Non-Detect

  ECT2 was approached by a remote refinery in Alaska that had found PFAS in their wastewater stream.

• Media Exchange In iPSC Cell Expansion And Differentiation: A Comparative Study

  Low-shear, closed-system media exchange in iPSC differentiation is vital for scalability. This study compares automated centrifugation to gravity sedimentation, showing equivalent or superior differentiation outcomes.