Pharmaco

Development

  1. Formulation development
  2. Analytical development
  3. 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.