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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

GENEPHARM S.A.
18km Marathon Avenue 15351 Pallini, Greece
Tel: +30 210 603 9336
Fax: +30 210 603 9402
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
GEMI REGISTRATION NUMBER 000276001000