Quality Systems

Hand in glove with CMC is the development of phase appropriate Quality Systems. We will work with your internal team, train your quality team, or serve as your Quality Assurance department to ensure and implement quality practices. We will develop SOPs and documentation practices that are required for your current product development stage. An initial Gap Assessment can be conducted to ensure compliance with Regulatory Agency requirements, including cGMP/GLP/GCP laboratory and manufacturing process controls. We can manage all of the critical relationships with CMOs, critical suppliers, and testing contractors in the US and internationally, including identifying and auditing appropriate contractors and developing Quality Agreements. Additional descriptions of our Quality System support services are found in the attached PDF.

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