Diapharm Analytics supports your quality control division – fast, reliable and uncomplicated. We can be your partner for R&D projects or operate as an extension of your quality control (QC) workbench: needs based, efficient, and with short turnaround times. We shoulder responsibility – since 1995.
Analytics and consulting
At our GMP-certified pharmaceutical laboratory, we test medicinal and related products, such as food supplements and medical devices, by applying modern instrumental analyses. These include chromatography (UHPLC, HPLC, IC HS-/GC, DC) as well as pharmacopoeia-specified tests. The Diapharm contract laboratory offers a combination of
- well-researched analytical and regulatory consulting,
- project management and
- practical lab work.
We know our way around the legal requirements and how the authorities enforce them in day-to-day business. This allows us to develop economical, targeted pharmaceutical analytics for every product.
Method development and validation
As one of the leading providers in the field of method development and validation, our contract laboratory develops valid quality-control methods that stand the test. This adds security to routine analysis – and freedom when flexibility is of the essence. We develop customised, targeted validation plans to demonstrate the suitability of the testing methods employed in marketing authorisation dossiers and many other regulatory tasks.
When it comes to routine analysis, we support our clients by acting as a reliable laboratory service provider to ensure efficient planning and stability testing of active ingredients, bulk products and finished products. We also monitor in-use stability and the shelf life of batches already on the market, i.e. on-going stability studies.
Laboratory with manufacturing authorisation
We set the highest standards for our operations, as verified by the GMP certification of our pharmaceutical laboratory. In addition to this, we have been granted a manufacturing authorisation for testing and batch release, in accordance with Directive 2001/83/EC, and are able to use our own QP-certified batch release testing to assist qualified persons in the process of batch release. Excellent services at a fair price – for us, this is all in a day’s work.