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WHITE PAPERS AND CASE STUDIES

• Revolution In The EU Pharmaceutical Legislation Ahead

  Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.

• Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer

  Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.

• Development And Regulation Of Veterinary Monoclonals

  Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.

• Achieving Self Sufficiency In Data Collection For Optinose

  Uncover how this specialty pharmaceutical company was able to gain control over its EDC environment by adopting a solution their team could use in-house.

• Simplify CAPA In 7 Steps

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

• Digital Endpoint Resource Guide: Obesity And Related Metabolic Disorders

  Explore how digital health technologies can enhance obesity treatment by providing critical insights beyond weight loss.

• American Academy Of Ophthalmology IRIS Registry Report

  The 2024 IRIS^® Registry Industry Report showcases the transformative power of real-world data (RWD) in ophthalmology.

• A Risk-Based Approach To Plasmid DNA And mRNA Process Development

  Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.

• Enhancing Data Capabilities For Greenville Water Utility

  The Greenville Water Utility in Indiana is leveraging Qatium to enhance its water management and leak detection capabilities, significantly improving service efficiency.

• Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning

  The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.

• Designing, Selecting, And Developing Bioconjugates For Clinical Success

  Accelerate the development of complex bioconjugates to unlock new possibilities for targeted therapies and advance the next generation of precision medicine.

• Strategies For Post-Approval Lifecycle Management And Local PV

  If you are unsure of how to navigate your post-approval regulatory journey, an experienced regulatory services partner can provide support to help you identify and achieve post-approval goals.