Services

1.      Development, optimization, validation and transfer of bioanalytical assays including immunoassays, cell-based assays and
         bioassays for GxP applications (GLP-assays, clinical assays and QC assays)

2.      Preclinical study support, data analysis & study report

3.      PK analysis for drug candidate selection and for IND-enabling PK studies

4.      Immunogenicity assessment and biomarker analysis projects

5.      Development of in-vitro and in-vivo models to support product testing

6.      GxP compliant laboratory set-up, validation, and preclinical and clinical study sample testing

7.      Writing, reviewing and auditing quality compliance documentations (SOPs, study protocols, validation reports, analytical
         reports, deviation reports, study reports)

8.      Writing and reviewing regulatory submissions (pre-IND/IND/CTA dossier sections, DMF)