Regulatory Affairs Support
SynCo has a strong track record in supporting clients through the manufacture of clinical trial material and licensed products. With this experience comes the expertise to be able to offer our clients support in their regulatory filings with respect to the CMC sections. SynCo’s full-time employed Qualified Persons (QP) and members of the Quality team work closely with our clients to ensure that potential 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. Over the years, SynCo has successfully supported its clients in a number of INDs, IMPDs, DMFs, MAAs and BLAs.
SynCo’s facilities have been a licensed manufacturing site for drug substance and aseptically prepared small volume parenterals (drug product) since 1992 and SynCo’s GMP license covers both clinical and commercial supply of biopharmaceutical products.
In addition to regular inspections by the Dutch regulatory authorities (IGZ) in accordance with EMA regulations, SynCo’s facilities have been inspected by the major international regulatory authorities (US FDA, ANVISA, MFDS and Health Canada) in view of the licensed products produced at SynCo.