Projects

Cell & Gene Therapy cGMP Facility

Assisted in the commercialization of two cell & gene therapy cGMP facilities. Services include development of validation strategy, interaction with regulatory agencies, review of facility design with architects and MEP engineers. Support construction, commissioning, and performance of defendable validation. Facility design reviews were facilitated with FDA as Type-C meetings. For Additional details Call - 484 844 3852.

503B Outsourcing cGMP Facility

Assisted with design, construction, Cx and validation of 503B outsourcing facility. Services included interactions with architects and MEP engineers, equipment vendors, attending FATs, Performing Risk Assessment, assisting with Cx and performing Validation activities for the aseptic sterile processing cGMP facility. For Additional details Call - 484 844 3852.

Biologics License Application (BLA)

Assisted client with preparation of BLA for an advance cell and tissue therapy, drug product for Type-1 diabetes. Assisted with migrating clinical data to comply with CDISC format, writing clinical summary reports, and compiling eCTD modules in making electronic submission of BLA to FDA. Obtained orphan drug designation, as well as coordinated FDA review meetings to review various aspects of the submission. Project also included assistance with design of a new cGMP facility, validation of equipment, cleaning, process, comparability protocol, to transfer manufacturing from one cGMP facility to another. For Additional details Call - 484 844 3852.