Novipart

Quality

  • More than 30 years of cumulated experience as Quality Directors (GMP, GCP, GLP, ISO 9001, ISO 14 001) in international biopharmaceutical companies
  • More than 50 audits performed in Switzerland and Europe according to GMP / GCP / GLP
  • Obtaining ISO 9'001 and ISO 14'001 certifications for 3 pharmaceutical companies together with implementing KPIs and Balanced Scorecards
  • Creation of a GCP/GLP Quality Assurance unit and of all required SOPs for a pharmaceutical company
  • Full revamping of the cell crisis manual of a pharmaceutical company and active management of crisis
  • Optimization of a waste management system in a pharmaceutical company (45% less costs, sorting ratio of 75%)

Innovation

  • Established of a company-wide management system program: 25-30 international projects worth 60-80 Million CHF and involving 50-70 people with less than 5% deviation in delays and costs
  • Building and installation of a state of the art biotech production facility: GMP status, 70 Million CHF, 2 manufacturing processes improved and accepted by the Swiss authorities
  • Established a global development plan for a biotech product including indications, formulations, regulatory pathway and market potential
  • More than 50 evaluations of licensing -in and -out opportunities with 4 negotiated and finalized agreements
  • Negotiation of a co-development and licensing-out agreement with a US-based pharma company leading to 10 Million CHF in milestone payments