Alerts
Clinical GMP Production
December 15, 2019
Flexibility and efficiency combined with regulatory compliance
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- 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’
expectations. - 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.
- Capacity to deal with limited amount and high value API with special requirements and strict