Methods development in accordance with regulatory documents
Check and processing of projects for regulatory documentation for pharmaceutical substances and drugs:
- theoretical verification of the ND project (evaluation of the correctness and completeness of the description of the techniques, checking the correctness of the calculation formulas);
- determining the need for reagents, CO, equipment required for testing methods of the ND project;
- experimental testing of the methodology of the ND project with the assessment of their reproducibility;
- refinement, if necessary, the methods of the ND project;
- provision based on the results of the report with recommendations and primary data.