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Our company constitutes of people with high practical experience in pharmaceutical regulatory affairs and medical writing. Company provides regulatory affairs services in EU for medicinal products (CTD dossier audits and medical writing, in and out-licensing, management of authorization, renewals and variation procedures, pharmacovigilance services and PIL readability testing services), medical devices (clinical evaluation reports, authorization of products and consultancy), food supplements, FSMPs and cosmetics including medical writing, eCTD publishing for EU and GCC region with consultancy on local requirements. Former authority experts.
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