Sharepoint Solutions
PRODUCTS
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The Composable MES for Pharmaceuticals provides a starting point for you to implement a tailored, connected production system with end-to-end traceability and right-the-first-time electronic batch records (eBR).
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Track and manage defects and non-conformances – such as SOP deviations or missing data – from identification to resolution.
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Forming part of 3P innovation’s Discover Range, this early-stage development unit uses two sets of die punches to compress pellets and seal them within a blister strip. Used predominantly for dry powder inhalers (DPIs), the ultra-compact filler fits on your lab benchtop.
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DispenCell Single-Cell Dispenser
A simple single-cell dispenser for proof of monoclonality
The DispenCell™ Single-Cell Dispenser is an automated laboratory instrument designed for fast, easy, and gentle single-cell isolation. DispenCell integrates seamlessly into your laboratory workflow, with a plug-and-play approach.
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Our goal is to help your business succeed by working with you to streamline the FDA regulatory process. ProPharma’s team of science- based regulatory consultants commands an unparalleled breadth and depth of knowledge pertaining to FDA’s regulatory framework and can work with you to accomplish your business objectives.
WHITE PAPERS AND CASE STUDIES
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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
Engage an experienced CMC program management consultant to collaboratively develop and maintain a robust product development plan (PDP) with your team lead, cross-functional members, and vendors.
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Solving The Silicone Challenge In Pre-Fillable Syringes
Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.
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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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How To Run Successful Clinical Trials In Japan
Read about why there is no longer any excuse not to include Japan as an integral part of any global clinical-development program for either pharmaceuticals or medical devices.
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Development Of A Non-Standard Protein Therapeutic
Discover how a tailored development approach transformed a complex therapeutic protein into a candidate ready for early-stage clinical trials.
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Medical Writing Support Relieves A Burdensome Review
Unearth how medical writing and project management teams were able to streamline the development and review of a critical marketing application document.
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A Comprehensive Planning Approach For Cancer Antibody
Discover how a clinical-stage biotech company was able to accelerate pathways for development and regulatory review of their first Phase 1 protocol for an immuno-oncology antibody.
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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).
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Why Early Market Access Planning Is Crucial In CGT Commercial Strategy
Bringing cell and gene therapies (CGTs) to market and ensuring patient access is a complex process. Discover how developing a market access strategy and partnering with experts can help.
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How To Manage A Drug Product In A Medical Device Environment
Discover how ProPharma successfully ensured GMP and GDP compliance for a drug product within a medical device environment.
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Performance Of Protein A Resins For Different mAbs
Review a Protein A resin solution assisting biotech companies who are working with and removing impurities from a wide variety of antibodies.
NEWS
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NOAA Sea Grant Advances Resilient Coastal Communities With $4M In Support1/10/2024
Sea Grant programs across the U.S. are scaling up capacity to support additional hands-on, collaborative engagement to advance the sustainability of coastal and Great Lakes communities.
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EPA Announces $194M To King County To Improve Wastewater Infrastructure Resiliency, Protect Puget Sound3/28/2024
Today, at an event at the West Point Treatment Plant, the U.S. Environmental Protection Agency Acting Assistant Administrator for Water Bruno Pigott announced a $194M Water Infrastructure Finance and Innovation Act loan to King County in Washington.
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Biden-Harris Administration Announces $94M WIFIA Loan To Upgrade Wastewater Infrastructure In New Lenox, IL3/11/2024
Today, the U.S. Environmental Protection Agency (EPA) announced a $94M Water Infrastructure Finance and Innovation Act (WIFIA) loan to the Village of New Lenox in northeastern Illinois.
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Moderna Receives Project Award Through BARDA's Rapid Response Partnership Vehicle Consortium To Accelerate Development Of mRNA-Based Pandemic Influenza Vaccine7/2/2024
Moderna, Inc. today announced a project award of $176M through the Rapid Response Partnership Vehicle (RRPV) to accelerate the development of mRNA-based pandemic influenza vaccines.
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Biden-Harris Administration Announces $42M Loan To Strengthen Water Infrastructure, Drought Resilience In Utah8/8/2024
Today at an event with Ogden Mayor Ben Nadolski, U.S. Environmental Protection Agency Deputy Assistant Administrator for Water Mae Wu announced a $42M Water Infrastructure Finance and Innovation Act (WIFIA) loan to Ogden City, Utah.