We specialise in the whole concept-to-market pathway.

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Our services include:

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• Formulations (new, reverse engineering, alternative excipients, etc);

• Patent searches;

• Specifications that comply with regulations;

• Stability testing;

• Manufacturing process advice (including acceptance testing of raw materials and in-process QC samples);

• Troubleshooting (including investigation for abnormal or out-of specification finished products and providing practical advice for remediation); and

• Ongoing after-launch support (including testing of field complaint samples).

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During the development process, we can help you with:

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• Chemistry, manufacturing and controls (CMC) strategy and project management;

• Regulatory document preparation for submission;

• Stability indicating analytical method development and validation; and

• PMA Root cause for OOS;

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During the technology transfer of a developed formulation, we can help you with:

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• Qualitative and quantitative composition of the product;

• Raw material specifications and test methods;

• Process information and cleaning details;

• In process controls, specifications and test methods;

• Product specifications and test methods;

• Packaging; and

• Master Batch Records.

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Please contact us to discuss your project.