Clinical Consulting provides transparent regulatory services for pharmaceuticals and medical devices.
Clinical Consulting Regulatory Affairs team
has dedicated resources which enable us to provide regulatory solutions to suport with a wide range of regulatory affairs encountered in preparation and throughout the conduct of each clinical trial.
Regulatory Services
Regulatory Strategy & Development Planning
Competent Authority and Ethic Committee submissions and communication.
and local regulatory consultancy and timeline guidance
LIAISON
with local regulatory authorities, EMA agency, Institutional Review Boards, and Ethics Committees in EU countries
APPLICATION PREPARATION
REGULATORY DOCUMENTS
Creation, preparation, execution and maintenance of regulatory documents for submission to industry sponsors, ethics committees, and regulatory authorities
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