Regulatory Compliance

SynCo’s facilities have been a licensed manufacturing site for drug substance and small volume parenterals (drug product) since 1992 and are regularly inspected on behalf of EMA by the Dutch regulatory authorities. 

In addition to EMA compliance, SynCo’s facilities have been inspected and approved by foreign regulatory authorities (Korean FDA, Health Canada and ANVISA) in view of the licensed products produced at SynCo that are registered in many countries outside Europe. 

Since several of SynCo’s clients have products in late stage development that will be launched onto the US market, SynCo expects multiple US FDA Pre-Approval Inspections (PAIs) over the next few years. The first PAI is anticipated for Q1, 2012 and additional PAIs are expected in 2012 and 2013. 

Next to the regulatory authorities SynCo is also frequently inspected by its clients or prospects for both the manufacture of drug substances and drug products.