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| Expedited regulatory pathways are being used more often, even as small molecule pipeline candidates grow in complexity, creating new risks for drug developers. Join Outsourced Pharma Live March 14th for a discussion with small molecule biopharma executives on the key considerations for CDMO selection, pitfalls to avoid with service providers, and tips for getting to the next development milestone. |
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By Erika L. Roberts, ELR Lab Services LLC | Benzene contamination in pharmaceuticals has led to product recalls and increased scrutiny in recent years. Recently, the FDA has asked the USP to remove a few monographs from the compendium due to safety concerns related to benzene's carcinogenic properties, and the agency has issued a new guidance to help industry navigate the reformulation of such drug products. |
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cGMP Manufacturing In The Pharmaceutical Industry | Article | Ascendia Pharma | Adhering to cGMP guidelines ensures that pharmaceutical companies offer customers a safe, high-quality product and that production will continue uninterrupted, reducing time-to-market and costs. |
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Controlled Substances | Cambrex | Cambrex holds U.S. Drug Enforcement Agency (DEA) licenses for process research, development, manufacturing, and importation of Schedule I to IV controlled substances. |
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Integrated Drug Discovery | LAXAI | Finding a partner with integrated services is crucial for accelerating timelines and accessing solutions with comprehensive expertise, all while removing risk from the drug product life cycle. |
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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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