Therapicon Srl

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Regulatory Affairs can offer a professional evaluation of regulatory procedures for your APIs and pharmaceutical Specialities to achieve best possible registration outcome.

Project Management

  • Project identification, planning, monitoring

  • Critical path analyses

  • Assistance for audits (preparation and support)

  • Analyses of product and company acquisitions and licensing opportunities

Regulatory Affairs

  • Expert review and regulatory gap analysis

  • Dossier analysis and validation

  • Assistance in preparation

  • Review of product development
    (pharmaceutical, toxicological and clinical aspects)

Documents & MAAs Procedures

  • CTD Formats, DMF and CEP procedures

  • MAAs via national, decentralized (MRP & DCP) and Centralized EU procedures


  • Submission applications to regulatory authorities, communications and follow up

  • Agents in leading pharmaceutical regions

is a registered trade-mark in Italy and at OMPI (WIPO)-Geneva

Copyright 2008-2012 - Therapicon Srl - Vat Nr.: IT08071680154 - Phone: +39 02 433042 - Fax: +39 02 48195224 |

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