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.

Chemistry, Manufacturing and Controls (CMC) Regulatory Support

Biomapas Regulatory team has the practical experience and essential knowledge in every aspect of Module 3 Quality, offering the preparation of the full document,
post-authorization changes assessment, variations preparation and management, and post-authorization strategic support while maintaining quality in all areas of CMC.

CMC Regulatory Services include:

  • Scientific/technical writing of Quality part for:
    • Investigational New Drug (IND);
    • Investigational Medicinal Product Dossier (IMPD);
    • New Drug Application (NDA);
    • Biologics License Application (BLA);
    • Marketing Authorization Application (MAA).
  • CMC life cycle management activities:
    • Change control assessment working with manufacturing sites and variations preparation;
    • Post-authorization maintenance and support through effective Life Cycle Management;
    • Preparation of responses to Regulatory Agencies questions;
    • Dossier amendment and supplement;
    • CMC due diligence and gap analysis;
    • Preparation, publication, and submission of Electronic Common Technical Document (eCTD).

Biomapas CMC Regulatory Support includes products of all types of APIs (Biologicals, Biosimilars, Chemicals, Herbals and Homeopathic). Our CMC team ensures smooth and flexible communication with Clients through effective project management in EU, US and EAEU markets, as well as preparation of documents at the highest quality standards meeting the regulatory compliance requirements.

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