We are a dynamically developing Polish private company operating on the pharmaceutical market since 2004. We offer consultancy services in the field of pharmaceutical projects potential evaluation, related to the development of medicinal products, medical devices and dietary supplements. We specialize in multidisciplinary services of Regulatory Affairs , including pre – authorization, authorization and post – authorization phases for medicinal products. We provide services in the area of non-clinical and clinical research. We have created a complete system for monitoring adverse reactions (Pharmacovigilance) that we offer to our Clients. We conduct GMP, GLP, GCP audits, and Pharmacovigilance system assessment. Our strength is the knowledge of legal requirements, guidelines, procedures and expectations of Competent Authorities as to the scope and quality of registration dossier. We also have an extensive experience gained through the realization of many registration projects carried out on behalf of pharmaceutical companies. We have been successfully carrying out medicinal product development projects from the concept till the implementation stage by ourselves for several years. Thanks to the developed solutions, we are able to perceive various possibilities, predict action scenarios, and above all, we are ready to respond to non-standard situations on an ongoing basis.
