PAT

we offer turn-key process analytical Technology solutions to the pharmaceutical and biopharmaceutical :

Examples:

• Laboratory, At-line, On-line, In-line

• Raw Material Identification

• Tablet Content Uniformity

• Blend Uniformity

• NIR application for pharmaceutical and biopharmaceutical

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Quality by Design

• For new products or existing products

• Develop strategic guidance to implement QbD to maximize product and process to reach the best compliance and manufacturing control

• Provide comprehensive training in QbD, concepts, Risk assessments, DoE, QbD Methodologies, and Regulatory requirements FDA, EMA, WHO, and Health Canada

• Evaluate product quality attributes: API, manufacturing, packaging...etc, and establish the desired product state

• Implement Risk-based assessment for product profiles, Establish QTPP, CQA, CMA, CPP relationships, and Design Space.

• Perform Gap analysis and adjust product quality to best fit desired quality