Novipart

Quality

  • Assess the conformity to Best Practices (GXP*, ISO 9001, ISO 14 001)
  • Perform GMP / GDP support such as: auditing (self-inspection, suppliers, sub-contractors), writing APQR, SMF and Quality Agreements, setting up documentation systems
  • Perform GCP/GLP support for audits of investigator’s sites, CROs and clinical pharmacies and laboratories
  • GXP* training and continuing education
  • Evaluate, conceive and complete regulatory files (EMEA, FDA, ICH)
  • Propose areas of improvements through efficient internal processes and KPIs
  • Complete and mitigate a multi-sector risk analysis to provide a simple decision tool kit

* GXP: Good Practices with X for Manufacturing, Distribution, Clinical and Laboratory

Innovation

Add value to the existing project portfolio through

  • Strategic planning approach
  • Value-chain analysis and development of core competencies
  • Finding the right partners for co-development and licensing-out options
  • Program governance to improve deadlines and allocation of resources in current project management
  • Optimize product portfolio through
  • Proposing alternative medical indications and new commercial segmentations
  • Analysing the potential of geographical expansion (regulatory and commercial prospects) and finding the right distribution partner (licensing-out)
  • Searching the right complementary products to the existing portfolio (licensing-in)
  • Proposing letters of intent, term-sheets, helping negotiate conditions and finalizing contractual agreements (licensing-in and -out)