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Contract Analytical Services & CMC Testing Programs

Contract Analytical Testing Services

SK pharmteco is an experienced provider of contract analytical services for the production of high-quality small molecule APIs and intermediates, high-potency APIs (HPAPIs), and controlled substances, as well as cell and gene therapy products, biologics, and vaccines.

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Contract Analytical Service Offerings

Raw Material Testing

Producing safe, high-quality pharmaceutical products begins with the right starting materials. SK pharmteco’s integrated analytical services support clients with thorough solutions for verifying purity, potency, physical properties, extractables and leachables, and other vital parameters of chemical compounds, reagents, and packaging components against both in-house and pharmacopeial standards, as well as complex biological inputs like cell lines and viral vectors.

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Stability Programs

Our analytical services team has the deep technical knowledge and specialized equipment necessary to assess the long-term stability of drug substances and drug products under a variety of conditions. We work with clients to develop a comprehensive testing approach and provide key documentation to satisfy regulatory guidelines.

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Safety Testing

SK pharmteco works closely with partners to develop customized safety testing solutions that fit the demands of their project and phase. Our extensive testing capabilities cover biosafety and replication-competent virus testing as well as the detection and analysis of elemental impurities, microbiological contaminants, and more.

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