Clinical GMP Production

December 15, 2019

Flexibility and efficiency combined with regulatory compliance

    • Capacity to deal with limited amount and high value API with special requirements and strict
      timelines. We offer process improvement, scalability and flexibility to meet customers’
    • Purposed built facilities for clinical manufacturing challenges at Liof Pharma: 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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