SynCo has a strong track record in supporting clients through the manufacture of licensed products and clinical trial material. With this experience comes the expertise of being able to offer our clients support in their regulatory filings with respect to manufacturing and quality control. Our Qualified Persons and members of the QA team work closely with our clients to ensure that appropriate issues are brought to light and addressed within the work program, as well as providing relevant and appropriate documentation and data in a timely manner.

Investigational New Drug (IND’s) or Drug Master Files (DMF’s) and Biologic License Applications (BLA’s)

SynCo has broad experience with assisting its clients with the submission of IND’s, DMF’s and BLA’s for biopharmaceutical products. SynCo’s Site Master Files has been registered for all its facilities and has been referenced in many IND’s and DMF’s and several BLA’s.