Technical expertise

APIs

We offer comprehensive regulatory support for our partners at all stages in the supply chain.

Our experienced team is in regular contact with the relevant authorities globally and can assist in the preparation and submissions required to obtain the following:

  • Active Substance Master Files (ASMF)
  • Certificates of Suitability (CEP / COS)
  • EU registration procedures (MRP, DCP, CP, National)
  • Import Drug Licences (IDL) in China, for APIs used for pharmaceutical use

 

We can also coordinate Good Manufacturing Practice (GMP) audits at our API manufacturing partners, as well as providing support to customers on how to reach the necessary standards.