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Development

  • Formulation development
  • Analytical development
  • Regulatory affairs
    Genepharm with its broad and significant experience in the regulatory affairs domain within the EU and global markets, is in a position to guide your candidate product through a successful submission process. We offer Regulatory services including:
    a. evaluation of scientific and technical data and guidance through development
    b. dossier compilation (including eCTD sequences)
    c. submission via DCP/MRP
    d. maintenance of marketing authorizations within EU (renewals, variations)
    e. liaison with competent authorities and keeping abreast of relevant legislation