Regulatory Affairs

Our full range regulatory affairs solutions and services are dedicated to delivering the highest quality support, assistance and regulatory approvals. We follow the needs of our customer and their portfolios, as we work with a wide range of product categories: medicinal products, medical devices, cosmetics, and food supplements.  Our Regulatory Affairs team has comprehensive expertise and assures quality and accuracy for each task. All team members have majored in life sciences.

eCTD and NeeS Compilation

Biomapas provides full support in Electronic Common Technical Document (eCTD) compilation and submission, as well as Non-eCTD electronic Submissions (NeeS). We use the eCTD Office software. Our team is fully prepared for new requirements and to provide services using eCTD format. Such requirement came into force on 1st of January, 2018.

Full scope eCTD and NeeS services include:

  • A full dossier review and eCTD publishing services;
  • Assessment of old dossiers, gap analysis, update of dossier to be compliant and ready for submission;
  • Converting your documents into eCTD/NeeS format;
  • Preparing the Dossiers in eCTD/NeeS for initial submissions/renewals/variations;
  • Managing the life cycle of your product(s).

For any inquiry regarding our services, please contact Biomapas Business Development team.

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