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Development and technology transfer.

Development


  • Development of pharmaceutical formulations.
  • Manufacture of pilot batches for new regulatory products.
  • Manufacture of batches for clinical trials.
  • Compilation of technical documentation required for module III of health registrations.
  • Development and validation of analytical methods.
  • Reformulation and optimisation of marketed products.
  • Scalability and validation of manufacturing processes.

 

Transfer of products


  • Compilation of dossier information necessary for the transfer of products.
  • Risk analysis regarding the new product.
  • Adaptation of manufacturing processes.
  • Transfer of analytical methods.
  • Selection and purchase of starting materials and packaging materials.
  • Analysis of starting materials and packaging materials.
  • Management of Artwork.
  • Planning of industrial batches.
  • Manufacture and Validation of Processes.
  • Finished Product Analysis.
  • Compilation and support of the documentation necessary for presentation of the corresponding Variations.
  • Texts for development and transfer.
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