Service

Transport of Samples

  • pick-up service directly from customer
  • transportation under qualified conditions, e.g. 2-8°C

Support of Registration Files

Preparation of documents for submission:

  • IMPD Investigational Medicinal Product Dossier
  • module 3: Quality
  • ASMF Active Substance Master File
  • QOS Quality Overall Summaries
  • QES Quality Expert Statements

Correspondence to authorities:

  • initiation of changes or extensions
  • Letter of Deficiency

Partnering Laboratories

  • identification of impurities
  • extractables / leachables
  • testing for pyrogenes in rabbits according Ph. Eur. 2.6.8 / USP
  • testing for abnormal toxicity in mice according Ph. Eur. 2.6.9 / USP
  • special techniques
    • XRPD
    • electron microscopy
    • NMR
    • LC-MS-MS
    • GC-MS
    • elementary analysis
    • etc..