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Regulatory submissions

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 Services

  • 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.

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