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Regulatory Affairs

Understanding regulatory requirements is insufficient if you don't know how, when and where to use them.


Through a comprehensive analysis and review, we’ll evaluate your dossier and pinpoint what’s missing - as well as the steps you should take to correct it. Our experts can find and resolve technical issues and problems in advance, avoiding costly delays and deficiencies.

  • Preparation and submission of dossiers for:
    • Investigational New Drug - IND
    • Clinical Trial Application - CTA
    • Investigational Medicinal Product Dossier - IMPD
    • Marketing Authorization Application - MAA
    • New Drug Submission - NDS
    • Generic Application
  • Pre-submission interactions with HAs
  • Dossiers for emerging countries (LATAM - Latin America, CEI - Commonwealth of Independent Nations)
  • Identifying right strategies and mitigation plans for each case
  • Support for Orphan Drug Designation (ODD) applications
  • Product evaluation for suitability under expedited programs, and Regulatory support for submission of expedited program requests


We present your file, and checking for reception, following up on progress and keeping you fully informed on your dossier's status.

Post Submission

We follow up to ensure that any dossier deficiencies are corrected and your Marketing Authorization is granted as fast as possible.

  • Implementation of post approval changes
  • Life Cycle Management: Renewals, Annual Reports.
  • Market Authorization Transfer (MAT) support
  • Product whole life-cycle maintenance