Di Renzo Regulatory Affair
Company Details
Company Introduction
Di Renzo Regulatory Affairs was founded in1985 by Sante Di Renzo, achemist and psychologist with a long- term experience inFarmindustria and in the pharmaceutical field. Our company benefitsfrom a highly professional working staff of about 40 people,including a large technical staff, and offers regulatory servicesin the field of medicinal products for human and veterinary use,medical devices, biocides, cosmetics, food supplements, dieteticproducts, homeopathic remedies, medicinal gas products,phytotherapy products.We offer advice on and preparation of localdocumentation for MRPs, DCPs, national registrations, variations,renewals and MA transfers. For the national phase, we are able todeal with the pricing dossiers and advice on reimbursement issuesfor Italy as well as to negotiate the price with the ItalianPharmaceutical Agency . We offer advice on preparation of thetechnical dossiers to obtain Ce certification of medical devicesand offer support on the registration of biocidal products. We haveunits that deal with Pharmacovigilance, drug traceability,scientific information and transformation of medicinal dossiersinto eCTD format. We avail ourselves of mother tongue translatorsfor the translation of scientific texts from/to English and Germanand if necessary we provide asseveration of the same at thetribunal. We cooperate with International consulting firms withlong-standing experience and with the main GLP accredited analysislaboratories. We are part of European networks of regulatoryconsultants . Our main office is situated in a strategic positionin the centre of Rome, not far from the Ministry of Health, theItalian Pharmaceutical Agency and the Istituto Superiore diSanit .
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