Sharepoint Solutions
PRODUCTS
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Platform of automated, single-use systems for tangential flow filtration at multiple scales.
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The DecFill LM-200 and DecFill LM-560 are compact, fully automatic labeling machines designed for the automated labeling of vials, bottles, syringes, ampules, cartridges, and other containers with self-adhesive labels.
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We want your product to move through the regulatory process, gaining approvals and ultimately helping patients. Using our industry leading knowledge and skills, we will meet you where you are – gaining approval: for the first in human trials, in development, at scientific advice, at the end of phase 2, or post approval. At every level, our scientific expertise and in-depth knowledge of therapeutic backgrounds have guided every client we have to a successful outcome.
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A global team of trusted experts for multi-phase clinical development.
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By combining purpose-built polymers and lipids, animal-origin-free reagents seamlessly blend into the AAV manufacturing process during transfection to dramatically increase AAV titers.
WHITE PAPERS AND CASE STUDIES
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Regulatory Considerations For Excipients Used In Lipid Nanoparticles
Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
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How eSource Reduced Benchmark's Protocol Deviations By Almost 40%
Explore how a leading vaccine site network selected CRIO to help address the challenges with it's use of paper charts in collecting source data.
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Challenges And Solutions In Lyophilization Development For ADCs
Successful ADC lyophilization requires a robust, individualized process driven by thermal characterization using DSC and FDM to define the critical parameters for stability and efficient manufacturing.
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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.
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Pioneering The End-To-End Decentralized Trial Experience
This collaboration highlights the potential of decentralized clinical trials (DCTs) to transform trial execution, as well as offering a replicable model for future research.
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Manufacturing Transfers: Delivering 140+ Precision Medical Devices Without Missing A Deadline
Go inside a successful manufacturing transfer of over 140 Class-III silicone medical devices and on-time delivery for a top-30 OEM through expert project management and rigorous validation processes.
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NuGenesis 9.3 – What's New
Explore the latest features of a user-centric lab management system that comprises data, workflow, and sample management capabilities to support the entire product lifecycle.
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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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Relieving The Strain Of Publishing During Regulatory Registration
Go inside how an expertly handled NDA submission for a biopharma company ensured timely FDA approval despite challenges.
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GMP Calibration Management
Learn why generic EAM systems fall short in regulated industries and how purpose-built solutions ensure compliance, efficiency, and audit readiness.
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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.
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NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission
A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).
NEWS
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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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Investigating The 'Glue' That Holds Cells Together3/20/2025
Northwestern Medicine investigators have uncovered new insights into how intercellular “glue” functions to enable interactions between cells, as detailed in a study published in Nature Communications.
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Latvian Scientists Create A Tool For More Efficient Public Procurement Evaluation1/10/2026
Much of public procurement evaluation consists of manual work by experts and specialists. This is time-consuming, since it involves comparing extensive documentation, evaluating compliance with regulatory requirements—like whether there are competition-restricting criteria—and other factors.
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New Research To Unlock Smart Sewer Potential For Water Utilities8/20/2025
A groundbreaking research initiative led by a multidisciplinary team of engineers and utilities has been launched to address the critical need for industry-wide guidance on smart sewer system implementation.
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Higgins, Timmons Introduce Legislation To Repeal EPA Rule On Chemical Manufacturing3/11/2025
Congressman Clay Higgins (R-LA) and Congressman William Timmons (R-SC) introduced legislation to repeal the U.S. Environmental Protection Agency’s (EPA) final procedural rule for new chemical reviews under the Toxic Substances Control Act (TSCA).