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| What's your development and manufacturing outsourcing strategy based on? Do you have the right contracts and external relationships in place to successfully implement that strategy? Are there new models for sponsor-CDMO partnerships? Join Outsourced Pharma Live on August 13th as our panel of professionals will provide personal analysis and ideas for determining how you might best conduct your development and manufacturing activities, outsourcing business models, and external relationships. |
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By Louis Garguilo, Chief Editor, Outsourced Pharma | "Back in the day," says Chief Editor Louis Garguilo, "it proved most optimal for my biopharma clients ... I’m speaking of the full-time equivalent (FTE) model at CDMOs for your drug development (and certain manufacturing) needs. Hooking up to specific professionals at your CDMO still makes good sense." |
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5 Recommendations To Maximize CSV/CSA Outcomes | By Ulrich Lein and Stefani Godoy Herrera, MAIN5 | The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need. |
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Customized Release Through Dispersed Dosage Formats | Article | By Nathan Dormer, Ph.D., Adare Pharma Solutions | Typically, dosage format is based on the target product profile: how the developer envisions the product best addressing a clinical indication by maintaining population-wide efficacy. |
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| PDA/FDA Joint Regulatory Conference 2024 | The PDA/FDA Joint Regulatory Conference 2024, the only FDA co-sponsored pharmaceutical CGMP conference, is taking place 9 to 11 September in Washington, D.C. Now in its 33rd year, the conference will offer a comprehensive agenda with substantive technical sessions and practical case studies that provide insight into the effective application of Current Good Manufacturing Practice (CGMP). |
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Nasal Spray Development And Manufacturing Services | Catalent | A partner with experts who are adept at working with complex, sensitive, and potent APIs; screening for the optimal formulation; and scaling up efficiently is vital for successful trials and commercialization. |
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Pharmaceutical Clinical Trial Distribution Services | Ropack Pharma Solutions | Contracting an in-country pharmaceutical clinical depot brings efficiency to your clinical trial distribution. We handle most paperwork, permissions, components, warehousing, packaging, distribution, collection, and destruction as a single project. |
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OUTSOURCED PHARMA CAPACITY UPDATE |
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CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs. |
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Connect With Outsourced Pharma: |
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