Product Development The Product Development department (PDe) of KLEVA Pharmaceuticals was established in 2002 for developing Kleva’s own formulations and in 2016 with main responsibility the pharmaceutical or nutraceutical product development service for third Parties, as well as our own developments. KLEVA Pharmaceuticals undertakes the development of a generic pharmaceutical product from the initial stages until the compilation of the pharmaceutical dossier in CTD format. These development stages include in brief: Patent search API sourcing Development strategy Quality control of the active substance Quality control of the RLD Formulation development Production of lab scale batches Production of pilot scale batches* Stability study of lab and pilot scale batches Process protocol and validation of pilot scale batches Compilation of the pharmaceutical dossier in CTD format *The stage is conducted at the manufacturing site of KLEVA under GMP conditions. KLEVA’s Product Development department has the flexibility to design the development of the product according to the requirements of each Client. The department was recently transferred at their newly established facilities at the 31st km Athinon- Lamias national road at Polydendri Attikis. The laboratory is equipped with the mandatory analytical instruments of the pharmaceutical industry which include among others: High pressure liquid chromatography UV-VIS spectrometer FTIR spectrometer FTIR spectrometer Dissolution Osmometer Viscometer Optical microscope with HD camera Along with the equipment for the manufacturing of laboratory scale batches, required for the test of the formulation of the product that is under development. PDe department personnel currently consists of highly educated and experienced scientists in the field of product, analytical and formulation development; analytical validation and dossier compilation. The department is growing rapidly in terms of equipment and personnel in order to respond to the highly increasing number of assigned projects. The graph below displays the new assigned project per year upon establishment of PDe. By this year; the PDe department of KLEVA pharmaceuticals has successfully delivered within the requested timelines; four (4) projects three (3) out of which were granted with a marketing authorization (EU and non-EU countries) while the forth is in the stage of assessment by the Authorities. KLEVA’s PDe department is equipped and experienced for the development of the following forms: Oral SolutionsOral suspensionsInjectableCreamsOintmentsTopical solutionsGelsTablets Currently developed formulations Tablets uncoated Modified release tablets Film or spray sugar coated tablets Hard gelatin capsules, containing granule powder or pellets (all sizes) Powders Granules Creams Ointments Gels Lotions Syrups Syrups with alcohol Solutions and suspensions Solutions for topical use Nasal sprays Aseptically filled/Terminally Sterilized products Currently; the department conducts the development of the following forms for products of various therapeutic areas as is displayed on the following graph. Ready for working together? Please contact us GET IN TOUCH Copyright © 2020 KLEVA Pharmaceuticals SA | All Rights Reserved. Κατασκευή ιστοσελίδων by Think Plus | creative & software agency We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it. Ok