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Operational Quality Assurance

Life Science industry is facing major challenges with a slowdown of the overall market growth, patent expiries, intense competition from generics, and tightening regulations that slow new product introductions. As a response to these challenges, the industry has massively invested in R&D (+50% in 8 years) and has launched a cost-cutting campaign to maintain the margins.

The innovative approach to optimize quality systems

With our field experience in regulations and best practices implementation, we go straight to the point to solve your day-to-day quality assurance issues, by using proofed methodologies and approaches.

  • ICH Q9 - Risk Management
  • ICH Q10 - Effective Pharmaceutical Quality System : Quality by Design focused on product and process , PAT...

We also have dedicated programs (coaching, mentoring, training...) to improve the maturity and the QA spirit of your teams.

 

 

 

 

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