Clinical Consulting provides transparent regulatory services for pharmaceuticals and medical devices: Regulatory Services - Regulatory Strategy & Development Planning - Competent Authority and Ethic Committee submissions and communication - Regulatory/ GMP Compliance.
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 Strategy & Development Planning
- Competent Authority and Ethic Committee submissions and communication.
- Regulatory/ GMP Compliance
EU Legal Representation
Under the terms of article 19 of the EU Directive 2001/20/EC in order to conduct clinical trials in the European Union, non-EU based sponsors must have a European company as their legal representative.
Clinical Consulting offers contract with Non-EU Sponsors to provide the required legal representative service including the responsibilities of the Sponsor with regards to GCP and regulatory compliance.