Phar.maluk Process.ing doo Information

Expert consulting service for pharmaceutical industry, new product development and project management. Support for the evaluation and selection of candidates for new products and pipeline management, enriching product portfolio with own development, in-licensing and products from merger & acquisition. The effective realization of high demands requested for the development, transfer, testing and registration of new drug products, medical devices, food supplements and cosmetics. Expert consulting for introducing and start-up of new technologies for production for drug manufacturing including all conventional techniques of manufacturing granulates and powder mixtures, compression, capsulation, film soaring and non-standard processes with functional coating, matrix system with modifies release, layering pellets and multiparticules, effervescent tablets, orodispersible tablets, gels, creams, suspensions and solution sterile or non-sterile. Project management, leading multidisciplinary teams to enable the company to develop, to register and launch new products. Planning, budgeting, control realization and execution and reporting for the whole project lifecycle: initiation of project, resource sourcing, defining the starting materials quality, preformulation studies, formulation and process development, leading development of analytical methods, manufacturing of pilot batches/scale up, having input in clinical tries, stability testing, documentation for registration in EU, SEE, Russia and CIS, managing registration procedures providing answers on deficiency letter, transfer to the production and to the QA&QC, performing production process validation and support launch. Application of Intellectual property knowledge in pharmaceutical development by finding freedom to operate. Innovation and preparation of own patent applications.