YOUR GATEWAY TO SWISS QUALITY & SERVICES

DCS PHARMA offers comprehensive services. Among them regulatory services, patent investigations and independent GMP audits.

REGULATORY SERVICES 

  • Active Substance and Drug Master Files (ASMF & DMF)
  • Quality Overall Summary (QOS) and Certificates of Suitability (CEP / COS)
  • Management of registration procedures (MRP, DCP)
  • Regulatory affairs services for Asian markets, e.g. Import Drug License (IDL) for China, JDMF for Japan, KDMF for Korea

GMP AUDITS & GMP SUPPORT

Reliable GMP audits conducted by APIC certified auditors. Additionally DCS PHARMA can provide support for API manufacturers to establish high level GMP standards.

REFERENCE SUBSTANCES

Substances listed in leading pharmacopoeias, though not available through e. g. EDQM and USP.

API IMPORT DRUG LICENSE CHINA (IDL) 

When importing API to China, we help with studies to understand the market and to establish import licenses (IDL) for both API and Finished Dosage Forms (FDF).