Quality

Quality Management is crucial to ensure product integrity and patient safety, as well as demonstrate the Sponsor’s commitment to ensuring compliance.  Our team can work with you to develop a Quality System and associated SOPs that meet the needs of your organization. Clear, concise, yet compliant procedures focused on regulated activities actually performed by your organization will ensure compliance with Agency expectations. Creation of a document repository will allow for organization of all critical documents needed to support the development of your drug.

Our staff can conduct audits and support the management of your vendors in compliance with regulations and current industry guidance. And when the time comes, we can also prepare your vendors for pre-approval inspections. Through development and implementation of an appropriate vendor qualification program, review of data collected and reports written, and review of associated regulatory filings for technical accuracy, our team provides the framework your ultimate large pharma partner will be looking for, or to be scaled as you proceed into later-phase development.