Therapicon Srl


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Consulting


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

Network

  • Submission applications to regulatory authorities, communications and follow up


  • Agents in leading pharmaceutical regions


Therapicon
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 | therapic@therapicon.com

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