Certified according to GMP. For reasons of data protection, please contact us directly if you would like to view our certificate, or search the EudraGMDP database.
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 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
IMP-Manufacturing
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. For reasons of data protection, please contact us directly if you would like to view our certificate, or search the EudraGMDP database.
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:
