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.

FDA projects.

-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.