Technology development and transfer

Development

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

Product transfer

  • Compilation of the dossier information required for Product Transfer.
  • Risk analysis related to the new product.
  • Adaptation of manufacturing processes.
  • Transfer of analytical methods.
  • Selection and purchase of raw materials and packaging materials.
  • Analysis of raw materials and packaging material.
  • Artworks management.
  • Industrial lot planning.
  • Manufacturing and Process Validation.
  • Finished product analysis.
  • Compilation and support of the necessary documentation for the presentation of the corresponding Variations.
  • Texts for development and transfer.