Quality control testing

Regulatory requirements:
National/international Pharmacopeias and competent authorities regulations, product specific test specifications, ICH and specific guidelines

Methods and equipment:
Physico-chemical tests, instrumental analysis including LC-MS/MS

Our Services:

  • Method Development
  • Method Validation/Verification
  • Method Transfers
  • Assay/Content
  • Impurities
  • Stability investigations
  • In-vitro dissolution

Specific services and experience (examples):

  • Heparin analysis
  • Mykotoxine analysis
  • Quality testing of products for inhalation
  • Quality testing of products for nasal application
  • Working with controlled/narcotic drugs

Batch certification/ QP Service

Our Services:

  • Human Medicinal Products: Import and batch certification
  • Investigational Medicinal Products (IMP): Import and batch certification
  • QP service consultation

Clinical Trial Supply

Regulatory requirements:
GMP Annex 13, national and international regulations

Our IMP Services:

  • Import and batch release
  • Packaging and labelling
  • Purchase of reference IMP products
  • Storage and distribution
  • Distribution and temperature controlled shipment
  • License for handling with controlled/narcotic products
  • GMP confirm documentation and archiving

Specific IMP services and experience (examples):                 

  • Preparation of Lab Manuals
  • Preparation of study specific supply boxes including Lab Kits, IMPs and/or concomitant medication
  • Management of distribution and monitored shipments to the clinical centres
  • Management of disposal of the IMPs


Our Services:                            

  • Manufacturing of semi-solids for nasal application
  • Primary and secondary packaging
  • Quality control testing
  • Import and batch certification

Factsheet / You can download a summary of our companies here.

DELPH-i GmbH Pharmaceutical Services
Schöntalweg 9, 63849 Leidersbach, Germany
+49 6028 1237870  I  mail@delph-i.de

Certified according to GMP

GMP Certificate

In cooperation with our partner companies ACC and Nova-Clin as well as our network, we complete and fulfil your needs for a successful product development, marketing authorisation and batch certification. Visit our partner websites: