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MEET THE NEW ICP-MS SERVICE

​Download our newsletter to know in detail the new service of elemental impurities analysis.

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LEF has a new ICP-MS laboratory

LEF has built a completely new laboratory which is designed to meet the new requirements of the pharmaceutical sector related to elemental impurities that can be found in medicines or similar products. The newly published guidelines require that the risk of certain elements, such as arsenic, cadmium, lead and mercury, be assessed in the final product.

First drug product produced in LEF

LEF has already a drug product produced in its Manufacturing Unit. It is a veterinary medicine based on megestrol acetate, which aims to prevent the onset of heat in dogs and cats, as well as to stop lactation caused by pseudo-gestation. LEF ensures the total manufacture of the drug product, from the stage of mixing, compression, blistering, to the secondary packaging.

Good Manufacturing Practices renewed

​​​​​​​INFARMED – National Authority of Medicines and Health Products, IP.  has renewed LEF's Good Manufacturing Practices (GMP) certification until 2019. With this certification, LEF ensures the fulfillment of all regulation requisites regarding manufacturing chain processes of non-sterile solids, semi-solids and liquids dosage forms, as well as certification and batch release.​

ISO 17025 ACCREDITATION RENEWED

​​On the 7th and 8th of June, The Portuguese Institute for Accreditation (IPAC) renewed the accreditation of the LEF for ISO 17025, which regulates the management system in test and calibration laboratories. This renewal is valid for one year, ending in June 2019. The LEF is accredited for the development, validation and implementation of internal methods (flexible accreditation) and compendial methods.