Development and validation of methods and procedures.
Innovative, new analytical procedures are not only required when drawing up market authorisation dossiers, they are also needed to control the quality of new plant-based products.
In this respect, PhytoLab develops and validates new test procedures - to meet the requirements of new legislation to the same extent as for officially regulated risk management procedures (Stufenplanverfahren) or committees (e.g. DIN/ISO committees, German Pharmacopoeia Commission, Federal Institute for Consumer Health Protection and Veterinary Medicine (BgVV) etc.). Methods and procedures developed by PhytoLab are also finding their way into regulations and standards in the USA (e.g. AOAC or USP) thanks to PhytoLab's membership in the Institute for Nutraceutical Advancement (INA), an official validation laboratory.
As far as the development of new methods and procedures is concerned, PhytoLab's customers not only benefit from our experimental and analytical experience, but also from the use of modern, computer-aided simulations of HPLC chromatograms. These offer PhytoLab a means of rapidly optimising all of the relevant chromatographic conditions to produce highly dependable HPLC methods, which can be easily adopted in the daily routine.
Methods can be validated in accordance with the pertinent ICH Guideline, if you wish, recording all of the raw data to produce comprehensive documentation of all relevant validation data in preparation for a final report.
