INSIGHTS ON DRUG DEVELOPMENT
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Transitioning From Academic Research To Drug Formulation And Development
The transition from academic research and studies to industry research demands that individuals master additional skills, sets different objectives, and defines “success” differently.
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Increasing Bioavailability With Amorphous Solid Dosage Formulations
Discover the challenges associated with pH-dependent solubility for oral tyrosine kinase inhibitor (TKI) drugs and how leveraging ASD formulation can help create more effective, patient-friendly drug products.
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Opportunities To Accelerate Allogeneic Cell Therapy
Learn more about the potential of allogeneic cell therapies to combine the efficacy of personalized medicine with the scalability, accessibility, and uniformity of traditional off-the-shelf therapeutics.
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Nitrosamine Impurities Deadline: Are Your Products Compliant?
The FDA nitrosamine contamination guidance set deadlines of Nov. 1, 2023, for risk assessment updates and Aug. 1, 2025, for full NDSRI limit compliance.
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The Fundamental Outsourcing Question All Sponsors Face10/24/2023
To end our Outsourced Pharma Live event on strategies for quality and regulatory outsourcing challenges, Chief Editor Louis Garguilo emphasizes the crucial question to ask when selecting a CDMO.
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How To Connect Quality And Regulatory “At The Hip”10/24/2023
Our Outsourced Pharma Live panel of experts introduce challenges and strategies to ensure your internal – and external partners’ – quality and regulatory professionals work together.
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File First In Europe, Then The U.S.?10/24/2023
Karla Knower, Global Head of Regulatory Affairs, Paradigm Biopharmaceuticals, answers a challenging question from an attendee at a recent Outsourced Pharma Live.
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The Nature Of Quality Management Needs To Change10/24/2023
In these 3 minutes, Bikash Chatterjee, an Outsourced Pharma Board Member, discusses how the current drug development and manufacturing landscape necessitates different approaches for quality teams.
DRUG DEVELOPMENT SOLUTIONS
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Quotient Sciences manufactures a range of dosage forms with a track-record of working with higher-value products that may require lower batch sizes in the market.
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Learn how harnessing a CDMO’s extensive knowledge and skills in dealing with controlled substances can help you advance your innovative psychedelic therapeutic safely and efficiently.
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Our expertise and capabilities enable us to meet the complex technical challenges of pediatric products and provide you with a unique integrated development solution.
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Learn how a partner with process development and manufacturing experience and an extensive track record of delivering new or optimized routes can help guide your project toward commercialization.
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Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, molecules need to become cures, fast. Because humanity needs solutions, fast.