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..