KLEVA’s Product Development department has the flexibility to design the development of a product according to the requirements of each Client.

Contract development services

  • Design of development strategy
  • Formulation development
  • Analytical method validation / verification and method transfer
  • Batch analysis and release of finished dosage form
  • Stability studies
  • Regulatory strategy
  • Dossier compilation

Contract development services

  • Design of development strategy
  • Formulation development
  • Analytical method validation / verification and method transfer
  • Batch analysis and release of finished dosage form
  • Stability studies
  • Regulatory strategy
  • Dossier compilation

Testing & European Release of third country products including:

  • Comparative Analysis
  • Comprehensive Scientific Study
  • Quality Risk Assessment

Risk Management including among others:

  • ICH Q3D Risk Assessment
  • Nitrosamines Risk Assessment & and analytical testing

Risk Management including among others:

  • ICH Q3D Risk Assessment
  • Nitrosamines Risk Assessment & and analytical testing

With more than

0

   years of
experience

0

active ingredients manufactured in our site

0

MAs granted
globally

0

formulations under development

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Please contact us

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