

Medical Device
Training on Root Cause Analysis and Change Control Management
Audit of subcontractors

Formerly Peptisyntha
Development and Manufacturing of Active Pharmaceutical Ingredients
Full review of the microbiological analysis and trend analysis process

Contract Developpement & Manufacturing Organization (CDMO) – Pharmaceutical products
Interim Management as Head of Quality (QC & QA), recruitment, Key Customer relationship

Natural food supplements
Qualified Person & Head of Quality & Regulatory ad interim

Vaccines Development & Manufacturing
Coaching & Mentoring on GMP Culture, Root Cause Analysis
FDA inspection preparation (mockup) and Responses To Questions
Full Review of Deviations Process and implementation in different manufacturing units