Regulatory Affairs Services And ECTD Publishing In EU For Pharma Industry
TopPharm Consulting - 1 month ago
Regulatory affairs services in pharmaceutical industry include not only management of processes like marketing authorizations, variations or renewals but also CTD dossier consultancy and preparation. Thanks to our experience in the field of pharmaceutical and medical sciences we offer you services and medical writing as well as process management for medicinal products e.g. preparation of clinical and nonclinical overviews and summaries, but also in and out-licensing of CTD dossiers, dossier audits as well as eCTD publishing for EU, Switzerland and GCC region with consultancy on local requirements. The services for medicinal products include also pharmacovigilance services and PIL readability testing and management of authorization, renewal and variation procedures. We offer also regulatory and consulting services for food supplements and FSMPs and medical devices including authorization of such products and support for borderline products as well as preparation of clinical evaluation reports.
Regulatory affairs services and eCTD publishing in EU for pharma industry Warsaw