Sharepoint Solutions

WHITE PAPERS AND CASE STUDIES

• 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).

• Expert Guidance For EU Gene Therapy And Companion Diagnostic Trial Regulations

  This playbook provides a concise yet comprehensive roadmap for navigating Europe’s multifaceted regulatory environment when conducting gene therapy trials involving GMOs and CDx.

• Advancing Oncology Innovation With Adaptive Trial Designs

  When a biopharmaceutical company developing a novel therapy for solid tumor cancers became concerned with rapid over-enrollment from within a single region, they employed a CRO for assistance.

• Gene Therapy For Mitochondrial Disease: A Guide To Emerging Regulation

  Learn how the FDA's expedited programs, along with the efforts of innovative companies, are paving the way for the development of effective gene therapies to address primary mitochondrial diseases.

• The Evolution Of SDV, SDR, And RBQM In Clinical Trial Data Quality

  Explore the inefficiency of complete SDV and how the adoption of technologies like centralized monitoring, remote SDR, and targeted SDV can enhance data integrity and cost-effectiveness.

• 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.

• Mobile Lab For A Large Pharma Client

  Completed in 2021, learn how this custom BSL-3 mobile laboratory received PHAC approval and ensured a secure environment for PPD powder-related MTech development work.

• Liposomal And Nanoparticle Technology

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

• Selecting A New Sporicidal Disinfectant: What The Cleanroom Manager Needs To Know

  This guide helps cleanroom managers evaluate sporicides by efficacy, safety, and compatibility to ensure contamination control without compromising operational integrity.

• Performance Dashboards Development

  Learn about a biotech company's successful implementation of a two-level KPI dashboard system. This enhanced performance monitoring, aligned departmental goals, and strengthened team communication.

• Expert Consulting And MRCT Strategy Rescues Oncology Program

  Uncover how this strategic approach yielded significant outcomes, including uncovering missing data through IB review, streamlining dosing timelines, and achieving successful recruitment milestones.

• OEE And Product Inspection

  Explore the calculation of Overall Equipment Effectiveness (OEE) and the impact of product inspection equipment on OEE in the pharmaceutical industry.