YOUR GATEWAY TO SWISS QUALITY & SERVICES

DCS PHARMA offers comprehensive services to support our partners in the supply chain, as well as to API manufacturers and applicants planning to introduce our generic APIs into their marketing authorizations.

REGULATORY SERVICES 

  • Support in the preparation of Active Substance Master Files (ASMF)
  • Support with submissions for obtaining Certificates of Suitability (CEP / COS)
  • Support for EU registration procedures (MRP, DCP, CP, national)
  • Support with obtaining Import Drug Licenses (IDL) in China, for APIs used for pharmaceutical use
  • General support based on our regular contact with authorities (EDQM, USFDA, NPMA, Swissmedic, AEMPS, COFEPRIS, ANVISA)

GMP AUDITS & GMP SUPPORT

DCS PHARMA can facilitate coordination of GMP audits at our API manufacturing partners for our customers. In addition, we can support our API production partners in reaching the required level of GMP standards.

API IMPORT DRUG LICENSE CHINA (IDL) 

DCS PHARMA can support our API production partners who are planning to enter China, helping them understand the market and obtain the required Import Drug Licenses (IDL).