Document Migration

PRODUCTS

  • Navigating both the specific country and general European regulations and requirements to supply medicinal products to the European markets can be a complex challenge. This applies both to Marketing Authorisation Holders (MAH) of approved commercial medicinal products and Sponsors of clinical trials.

  • For successful regulatory outcomes, we provide quality medical writing services for clinical trial documents, safety updates, and marketing applications.

  • From product development to translation into clinical trials, GTx’s clinically validated scalable electroporation technology is equipped to handle your most complex cellular engineering demands.

    • Rapidly transfect from 75 thousand to 20 billion cells
    • Move forward with 21 CFR Part 11 enabled software
    • Develop quickly with an established regulatory path supported by a FDA Master File
    • Manufacture confidently with closed, cGMP-compliant, ISO-certified and CE-marked products
    • Enjoy MaxCyte’s proprietary Flow Electroporation® technology
  • Manufacture high-quality products with streamlined compliance.

  • Discover how a collaborative approach to medical writing ensures the highest standards of excellence and precision in every document produced.

WHITE PAPERS AND CASE STUDIES

NEWS