Clinical GMP Production

“Flexibility and efficiency combined with Regulatory compliance”

 

  • imgfab3Capacity to deal with limited amount and high value API with special requirements and strict timelines. We offer process improvement, scalability and fexibility to meet customers’ expectations.
  • Purposed built facilities for clinical manufacturing challenges at Praxis: Timelines, Efficiency, Versatility and Scalability, Regulatory Acceptance (GMP) and Costs.
  • Special equipment for easy format changing, featuring CIP and SIP processes, designed for highly efficient small-medium batch production.
  • Manual processing validated for small batches of glass vials, syringes, plastic ampoules and other eye drop containers.
  • Maximum Flexibility (single use materials, cold compounding, absence of oxygen, light protection, etc.)
  • Preclinical and clinical batch production (Phase I, Phase II, Phase III) with manual, semi-automated and automated filling validated processes, matching all customer needs.
  • In house release of clinical batches (QP) and experience to provide regulatory support for the CMC sections of pre-clinical and clinical applications.

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