Lab-Analytikal Conseil

Expertise and Analytical Consulting in the following areas-Development and optimization of analytical methods o Forced degradation study (chemical, heat and light according to ICH Q1B) o Robustness of the method o Writing development report -Validation of analytical methods o Proposal for experimental plan (according to ICH Q2 (R1/R2)/ accuracy profile method) o Protocol writing o Statistical analysis and interpretation of results (Enoval® / NeoLiCy® / Excel) o Writing validation report -Transfer of analytical methods o Protocol writing o Statistical analysis of the results o Report writing -Consultancy for the analysis of peptides for pharmaceutical use, analysis and sequencing of peptides by HPLC-MS/MS -Consultancy for the development of dissolution tests o USP1 / USP 2 / USP 4 / USP 5 -Advice on the implementation of stability studies according to ICH Q1A (R2)-Writing of analytical parts of regulatory files o CTD (Common Technical Document) o IMPD (Investigational Medicinal Product Dossier)-Project management o Search for partners (subcontractors and suppliers) o Material sourcing o Cross-functional management -Scientific support -Advice for structuring a pharmaceutical analysis laboratory (QC or R&D)-Qualification and validation of cleaning of laboratory glassware