Sharepoint Solutions
PRODUCTS
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Werum PAS-X as a Service delivers a fully managed, cloud-based MES for pharma and biotech, enabling rapid deployment, scalability, cost savings, compliance, and operational efficiency.
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Aizon Execute V2.1.0 is here — and it’s packed with powerful new capabilities designed to make digital batch execution even more flexible, efficient, and intelligent.
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The XD 7000 and XD 7500 Spectrophotometers combine a state-of-the-art optical system with ease of use and flexibility for a wide range of water testing applications.
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AST’s aseptic processing solutions are outfitted with the latest in intuitive cGMP technology designed to optimize the fill-finish process for the highest standards of quality and regulatory compliance.
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Referenced in the new USP <1207> Chapter Guidance as a deterministic test method for container closure integrity testing.
WHITE PAPERS AND CASE STUDIES
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The Role Of A Consulting Firm In The IND Process
Navigate the complex IND process with expert guidance and discover how early FDA engagement can accelerate your path to clinical trials.
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Organizational Assessment For A Large MedTech Company
Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.
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Strategic Pre-IND Consulting For Gene Therapy In Rare Leukemia
Learn about the collaborative efforts of an innovative biotech startup and Ergomed Consulting to overcome challenges in the pre-IND phase for a novel gene therapy targeting a rare form of leukemia.
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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.
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Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 Study
Explore the success story of an early-stage clinical pharmaceutical company that effectively navigated funding constraints when conducting its Phase 1 study without a third-party CRO.
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Improving Patient Health and Safety: Quality and Analytical Scientist
Explore how an analytical scientist enhanced quality and compliance for a pharmaceutical company by managing complex analytical testing and vendor interactions.
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Achieving Faster Timelines And Cost Savings Through Digital Validation
Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.
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Project Orbis Drug Registration 2025
Project Orbis helps streamline the review and approval of oncology medicinal products through international regulatory collaboration. Learn how this framework can accelerate your regulatory strategy.
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Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration
A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.
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CRO Leverages Integrated Central IBC Partnership To Initiate Sites
Learn how a CRO was able to accelerate review times so COVID-19 vaccine trial sites could progress through site selection, IRB/IBC submission, approval, drug shipment, and complete site initiation visits in record time.
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A Digital Solution Embeds Quality Into Cellular Therapeutics Production
Discover how Dendreon cut review and release time by nearly 50% while maintaining a 99% right-first-time rate, which boosts collaboration, visibility, and operational efficiency across teams.
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Patient-Defined Recruitment: The Movement Advanced By COVID-19
The pandemic forced the pharmaceutical industry to reimagine how we recruit patients to clinical trials – and it's delivering significant benefits to sponsors who embrace these changes.
NEWS
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Axim Biotechnologies Files Pre-Submission With FDA For CLIA Waiver Pathway On Lactoferrin Point-Of-Care Diagnostic Test6/24/2025
Axim Biotechnologies, Inc. a leading developer of rapid diagnostic testing for ocular and systemic conditions, today announced that it has filed a Pre-Submission (Pre-Sub Q) with the U.S. Food and Drug Administration (FDA) as the first formal step in seeking a Clinical Laboratory Improvement Amendments (CLIA) Waiver for its rapid, point-of-care Lactoferrin diagnostic test (TearScan Lf).
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Merck To Acquire US Biopharma Company SpringWorks Therapeutics To Accelerate Sustainable Growth Of Healthcare Business4/28/2025
Merck, a leading science and technology company, and SpringWorks Therapeutics, Inc., a Stamford, Connecticut-based commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced the companies have entered into a definitive agreement for Merck to acquire SpringWorks.
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Global Hydrogen Market: Uniper And thyssenkrupp Uhde Sign Framework Agreement On The Use Of Ammonia Cracking Technology11/26/2025
Uniper and thyssenkrupp Uhde have signed a framework agreement that lays the foundation for the construction of commercial ammonia cracking plants.
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Safeguarding Citrus: International Collaboration Between Australia And Indonesia, Targets Huánglóngbìng Threat6/25/2025
NSW Department of Primary Industries and Regional Development (NSW DPIRD) has reaffirmed its commitment to protecting Australia’s citrus industry through international collaboration against huánglóngbìng (HLB), also known as citrus greening disease.
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Pittsburgh Water Receives $26M In Grants And Low-Interest Loans From PENNVEST1/23/2025
Today, Pittsburgh Water announced the receipt of $26M in grants and low-interest loans from the Pennsylvania Infrastructure Investment Authority (PENNVEST) to continue the diligent removal of lead service lines throughout Pittsburgh’s drinking water system.