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Clinical Scale-up and Supply |
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Small Molecule Services |
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One of the most challenging areas faced in drug development is scaling up chemical processes to generate larger quantities of material needed for clinical trials. The production of a drug substance for administration to humans must be conducted in accordance with a tightly controlled regulatory environment. Compliance with these regulations requires extensive knowledge and experience. SAFC Pharma can offer the reassurance of an experienced cGMP manufacturer proficient in dealing with these challenges.
Scaling up chemical processes to yield larger quantities of material for clinical trials is a challenging area faced in drug development. A supplier must combine significant chemical expertise with an ability to manage the tightly controlled regulatory environment required for cGMP manufacturing compliance. Combining these capabilities requires extensive knowledge and experience. SAFC Pharma has successfully provided scale up and clinical manufacturing services for over 20 years.
| Services Overview |
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Raw material sourcing |
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Chemical process feasibility |
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Process development |
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Analytical development & validation |
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Process validation |
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cGMP manufacturing (grams to tons) |
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Regulatory services (DMF submissions & CMC support) |
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