Clinic pharma can be of help in the following fields: registration of medicinal products;, clinical studies, phase i - iv, including non-clinical;, piggy-back trials;, pharmacoeconomic analyses (including reimbursement application);, training of employees;, scientific matters. Divisions of clinic pharma: regulatory affairs: mutual recognition procedure (mrp), national registration, expert reports, translations, registration of clinical trials, our service include: application for registration of medicinal products, monitoring of registration process, direct contact with drug registration agency, all kinds of experts reports or overviews, help with mrp including translations, rx or otc switch, and use of bcs in generic applications, our experience: 14 mrp procedures finalized, numerous expert reports & overviews mostly chemico-pharmaceutical and clinical, numerous successful variations, numerous translations and handling: summary of product characteristics and patient leaflets, clinical studies: bioequivalence, phase i & ii studies, phase iii (in cooperation), phase iv (in cooperation), pharmacoeconomics, training, scientific matters: manuscripts, consultations. .
