Regulatory & Ethics
Argint's regulatory department is responsible for preparation of Clinical Trial Applications. The team is led by Eva Halaszi MD who is supported by Regulatory Associates responsible for submissions in each country. Dr Halaszi has personally supervised more than 600 ’Initial Requests for Authorisation of Clinical Studies’ to competent authorities within Europe during the past 12 years. Dr Halaszi liaises directly with regulatory personnel within client companies to ensure all dossiers delivered to Competent Authorities and Central Ethics Committees are complete and contain the highest quality of documentation possible.
Argint's regulatory team provides advice and guidance to clients on all aspects of compliance with EU directives and local legislation. The team have excellent relationships with the local Authorities and often advice can be sought on any specific question that is not clearly answered or defined in the legislation.
Argint is able to provide scientific regulatory services, such as preparation of the IMPD and IB, via our partners.
Legal Rep in EU
Article 19 of the Clinical Trials Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 requires non-EU sponsors of clinical trials to have an established legal representative in the EU. Argint provides a full legal representative service for our non-EU clients.