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Regulatory Affairs

Worldwide Support since 1997

Many of our high quality fine chemicals and ingredients meeting various quality standards.

Compliance offerings:
cGMP (pharma), Pharmacopeia grades, US-FDA / EMA accredited facilities
cGMP (food), Food grade, FCC, Kosher, Halal, HACCP, non-GMO, vegan
GMP+ (feed)
ISO 900x

We are assisting our partners in various countries with

  • Audit management service / Audit assistance (including remote)
  • CEP/DMF – CTD/ASMF and Written confirmation support
  • Fulfilling REACH requirements
  • Implementing and monitoring change control systems worldwide

As for R&D support and custom synthesis/manufacturing services please explore our manufacturing services.