Laboratory for method development and stability testing
Diapharm provides fast, reliable and uncomplicated support for analytical quality control, testing of medicinal products and related products such as food supplements and medical devices at our testing laboratory. We have the necessary equipment to deal with these services, including chromatography (LC, GC, TLC) and titration testing in accordance with international pharmacopoeias like dissolution testing.
We are fully acquainted with the legal requirements and know exactly how the regulatory authorities interpret them, so we can develop analytical methods optimised for your needs for each product. As a reliable service laboratory we assist our clients by providing routine analytical services for ongoing stability testing and batch release testing with QP certification.
Our laboratory services include:
- Analytical consulting
- Method development and method validation
- Project analysis
- Stability testing
- Batch release testing
We also set very high standards for our own operations - our GMP / Good Manufacturing Practice certificate, which is renewed regularly, verifies this. We have been granted a manufacturing authorisation for testing and batch release as defined by Section 13 (1) of the German Drug Law (AMG) and, with this capability, our laboratory can provide clients with QP-certified batch release testing, e.g. for companies from outside the EU.
Excellent services at a fair price – for us, this is all in a day’s work.
