|
Regulatory Affairs.
With over 30 years of local and international regulatory experience between
them, ERGOMED’s Regulatory Affairs group can provide a complete regulatory
service: from advice on registration strategies, through regulatory support
of clinical trials, to Orphan Drug Applications and the compilation and maintenance
of Marketing Authorization Applications.
To support a clinical development program, ERGOMED provides complete regulatory
cover in each European country, enabling to fully comply with current national
and international regulations. ERGOMED has a history of successful co-operation
with Regulatory Authorities and Ethic committees in all 20 European states
in which it currently operates, what is ensuring a rapid study start-up. This
support is particularly valuable in Central and Eastern Europe, given the rapidly
changing regulatory environment in this region.
Regulatory support of clinical trials refers to:
An initial assessment of your data to maximize the possibility
of rapid clinical trial approval
• Preparing submissions for clinical trial and Ethics committee approval
• Reviewing the submission to ensure all essential regulatory clinical
trial documentation is in place and correct, with translations provided as necessary
• Submitting timely applications for clinical trial approval and ensuring
continued regulatory compliance by maintenance of the application
• Communication with Regulatory Authorities, including notification of
expeditable serious adverse events
• Assistance with drug supply and labelling
• Collecting, reviewing and updating all national legislation related to
clinical trials to ensure full compliance with all applicable requirements
|
