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Formulation

Formulation development is carried out based on the Final documentation and evaluation prepared according to the aforementioned and depending on the available machinery. We determine the final composition, the production processes and technology, taking into consideration the user friendly implementation aspects and the strategic and registration objectives of the company. Formulation means the following activities:

  • Evaluation of preformulation solubility and stability
  • Selection of final additive and supplier rating
  • Development of the prototype
  • Formulation optimisation and finalisation
  • Determining specification
  • Documentation and data package complying with the CTD/eCTD format, QoSr requirements

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