Records Management

WHITE PAPERS AND CASE STUDIES

• Scaling With The Client In Mind: A Customer-Centric Approach To Project Scale-Up

  In today’s fast-moving biopharma landscape, scaling from clinic to commercial takes more than expertise. See how collaboration can transform scale-up and drive confident progress

• Optimizing Chronic Cough Phase 3 Trials With Point-Of-Need Eye Assessments

  Collaboration was key for Company W to overcome challenges with an FDA-mandated ocular substudy, including limited resources for ocular assessments and logistical difficulties

• Preparing For Disease X: Effective Vaccine Development In The Face Of A Future Pandemic

  CDMOs are playing a critical role in the global effort to prepare for future pandemics. Learn how innovative strategies and flexible platforms are helping to ensure a swift and effective response plan.

• Cell Collection Basics For The Transplant And CGT Industries

  Breakthroughs in CAR T-cell and stem cell therapies depend on mastering cellular collection. Understanding these fundamentals is vital for advancing treatment efficacy and patient outcomes.

• Case Study: Flat Creek Water Recovery Facility

  In this case study, learn about a city that worked with ChartWater™ to provide emergency, supplemental oxygenation using BlueInGreen’s supersaturated dissolved oxygen (SDOX®) technology.

• Boosting CMC Regulatory Efficiency In Gene Therapy

  Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.

• Decoding A B-Cell Fingerprint: All You Need To Know

  Explore how, much like a fingerprint, each B-cell possesses a unique identity, and how deciphering this code can unlock a wealth of possibilities in antibody development, immunotherapy, and beyond.

• Blueprint For Early Phase Clinical Pharmacology Studies In Dermatology

  Explore the landscape of dermatological drug development through a comprehensive framework for rational early-phase dermatological trials, centered around five foundational pillars.

• Modernizing Operational Maintenance At Treatment Plants

  In 2017, the Harford County Division of Water and Sewer began looking for a modern work management solution to help automate preventive maintenance, coordinate work activities between groups, manage material inventories, and capture important data.

• Re-Engineering A Complex Process For FDA Compliance

  Discover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.

• Tackling The Cost Of Poor Quality: Strategies And Solutions

  Don’t let the cost of poor quality hold your business back. Discover how a modern QMS can transform your operations and drive success.

• Seizing Market Share Pre-Patent Expiry: The Evolution Of A CDMO Partnership In Navigating A Paragraph IV ANDA Submission

  The dynamic pharmaceutical landscape demands agility and strategic foresight. Explore how leveraging a key partnership helped to overcome a looming patent expiry for a second-generation acne medication.