Our Clinical Product Development Services

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Formulation/Process Development

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• Permits the manufacture of drug products on demand to meet the precise needs of the clinical trial and patient recruitment without substantially changing formulation composition and manufacturing process

• Allows generation of sufficient stability data throughout the development phases that help establish specs at the time of registration and commercialization of new molecular entities, including fast track and breakthrough products since the formulation composition and manufacturing process remain practically unchanged

• Requires limited scale up activities when transitioning from development to commercial manufacturing

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Dosage Form Development

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• Drug candidate performance optimization

• Dosage form performance optimization

• Analytical Methods Development

  • Assay

  • Related Substances

  • Dissolution

  • Cleaning verification

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Dosage Forms

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• Compressed tablets

• Compression-molded tablets

• Pellets in capsules

• Powder in capsules

• Satches

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Regulatory​

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• Development report

• CMC Documentation Support