Liof-Pharma is a CDMO organization that offers reliable and high-quality services throughout entire product life cycle. Our compliance program is based in a robust quality management system & strong compliance culture with ultimate focus on patient safety. We understand the vital importance of strictly adhering to current applicable legislations & guidelines as the unique way to obtain safe, quality and effective products.
Liof-Pharma holds authorization for the manufacturing of aseptically prepared lyophilizates and small volume liquids of different type of biotech products, such as:
– Immunological products
– Cell therapy products
– Biotechnology products
– Tissue engineered products
Liof-Pharma also holds authorization for secondary packaging activities and quality control testing, has been EU GMP certified by the national Health Authority (AEMPS, Agencia Española de Medicamentos y Productos Sanitarios) and has been also approved by different international health authorities, amongst others:
– ANVISA (Brazilian Health Authority)
– Ministry of Health from Kuwait
– Ministry of Health from Turkey
– Health Authority from Cuba (CECMED)
Our facilities have recently undergone also a pre-approval inspection (PAI) waived by the FDA. We have consistently delivered this level of quality for clients year after year for more than 10 years. Liof-Pharma sustained also ISO 13485:2016 certification for the manufacturing of medical devices.
In house Qualified Person
Liof-Pharma offers in house Qualified Person (QP) service. The QP, responsible for certifying batches of medicinal products, has the ultimate responsibility to ensure the quality of medicines and the fulfilment with the requirements set down in each product license. Liof-Pharma has a QP as well as a deputy QP, both with wide experience in pharmaceutical industry and in medical devices field and with an in-depth understanding of the factors that can affect the quality, safety and efficacy of medicines and supply chains.