Here is just a small sampling of some of the projects we have successfully completed over the years.

Completed Projects

• Managed to completion the qualification and start-up of a multi-product biological manufacturing facility used for production of clinical drug substance,

• Successfully completed qualification for expansion of large scale chemical API manufacturing facility used to produce API for breakthrough antiviral therapeutic,

• Provided cGMP facility design review for several new biologics manufacturing facilities. 

• Successfully performed data integrity gap analysis for numerous complex computerized systems, developed remediation plans for each system, initiated CAPAs, change controls and assisted in closeout of data integrity gaps.

• Performed technology transfer of vaccine manufacturing processes to two separate third-party contract manufacturers.

• Completed development work and technical studies used to justify several successful FDA submissions for post-approval license changes for various biological products.

• Supported launch of several new viral vaccine products through validation of the manufacturing processes and assisting in the development of regulatory submissions.

• Led process validation efforts for the remediation of FDA Form 483 observations related to the filling and lyophilization processes for multiple bacterial and viral vaccine products

• Created aseptic process simulation program for validation of aseptic filling process for gene therapy product.