GxP Compliance and Third Party Audits
-Implementation of Pharmaceutical Quality Systems ICH Q10 and GMP requirements updating.
-GDPs implementation. Quality Manual and procedures.
-GMP/GDP/GLP audits: Auditors with international experience. Manufacturing and control of DP, API, excipients, medical devices and food supplements. Development: CROs, bioanalysis, CMC.
-Risk analysis: Customised training and expert facilitators to lead risk analysis projects: development, validations, process etc.
-GAP Analysis and report with reccommendations to adapt operations to FDA requirements.
-Review of CMC documentation to fullfill Question Based Review in generic products. Adaptation to ICH Q8 / Q11 Guidances
-Review of Quality System and Quality Control operations and procedures.