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