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
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
Download:
GMP Certificate
MIA
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:
