Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• Navigating Digital Transformation For Pharmaceutical CDMOs

  Discover how CDMOs can modernize operations, safeguard data integrity, and improve audit readiness with practical strategies for connecting systems and reducing validation burdens.

• GMP Calibration Management

  Learn why generic EAM systems fall short in regulated industries and how purpose-built solutions ensure compliance, efficiency, and audit readiness.

• FDA's Regenerative Medicine Advanced Therapy (RMAT) Program

  RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.

• Microbial Challenge In-Use Studies

  Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care.

• Navigating The Complexities Of Pre-Filled Syringe Manufacturing

  Drawing on our extensive expertise in sterile injectables (SI), here, we highlight practical strategies and proven solutions designed to help navigate challenges and support the reliable, scalable production of high-quality PFS therapies for patients worldwide.

• Enabling CDMOs To Focus On Core Priorities

  Explore innovative solutions for CDMO's striving to remain competitive as the biopharmaceutical market grows and evolves.

• eSource Purpose Is Not Just To Complete The EDC

  Central eSource transforms data capture from a passive, back-end chore into an active, real-time quality and compliance engine—delivering benefits that extend beyond faster EDC feeds and reduced SDV.

• Liposomal And Nanoparticle Technology

  Specializing in oncology, anti-infective, and complex formulations, Pfizer Melbourne provides manufacturing services for sterile dosage forms.

• The Latest Trends In The Prevention And Treatment Of Cervical Cancer

  What immune checkpoint inhibitors are showing promise in cervical cancer treatments and how are advancements in treatment, paired with additional prevention strategies, improving patient outcomes?

• Reducing Risk And Timelines In Cell Line Development

  Accelerate your biologic development by adopting faster, more reliable clone selection methods that reduce time and resources while improving the likelihood of identifying stable, high-producing cell lines.

• PEG In LNP Formulations: Addressing Challenges And Seeking Solutions

  Polyethylene glycol and similar variants have driven innovative research for therapies. However, the continued use of PEG poses significant drawbacks.

• Designing More Representative Trials Through Strategic Planning

  Strategic planning for representative clinical trials improves outcomes, regulatory alignment, recruitment efficiency, and commercial value by ensuring study populations mirror real-world patients.