Method Development and Validation
Whether it concerns the design of a new method or the improvement of an existing one to bring it in line with the latest technology, method development has many facets. Often, regulatory updates or changes will necessitate the development of methods.
On behalf of our clients, DSI-pharm develops concept-based scientifically sound and cost-effective analysis methods. The pharmaceutical laboratory also drafts development plans and reports, testing instructions, and validation plans and reports.
The transfer of methods to clients or third parties is supported with coordinated method transfers. DSI-pharm also provides coordinated project management, drawing on external qualified partners as required.
To gain marketing authorisation or registration of a medicinal product, the validity of test methods has to be demonstrated. DSI-pharm assists clients in creating appropriate validation plans and validating methods in accordance with ICH guideline Q2(R1). If the need arises, the company also manages the transfer of methods to routine laboratory analysis, including the drafting of transfer plans and reports. On-site assistance guarantees a safe method transfer. Our experts can implement the method directly in your laboratory processes.
As a matter of course, DSI-pharm also offers adequately customised validations for related product categories, such as food supplements, cosmetics or medical devices.
Using validated and robust methods brings reliability to your routine processes. At the same time, it gives you the necessary scope to manoeuvre, when flexibility is required.
- Chromatography (UHPLC, HPLC, IC, HS-/GC, TLC)
- Pharmacopoeia specified Tests (Physical Parameters, Osmolality, Dissolution Tests, etc.)
- Spectroscopy (UV-Vis, IR, NMR)
- Automatic Titration incl. Karl Fischer
- Blood Coagulation Analyser