Regulatory submissions

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.
  • Regulatory/ GMP Compliance

Our experience includes:

and local regulatory consultancy and timeline guidance
with local regulatory authorities, EMA agency, Institutional Review Boards, and Ethics Committees in EU countries
Creation, preparation, execution and maintenance of regulatory documents for submission to industry sponsors, ethics committees, and regulatory authorities

Our approach is:

Strategic analysis
of the appropriate regulatory needs
Advanced planning
to meet timelines
with regulations

Our partners

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משרד ורשה

יאנה פאולה II 27

00-867 ורשה, פולין

+48 32 227 20 05

משרד ראשי

רחוב דזבונקובה 104

43-100 טיכי, פולין

+48 32 227 20 05

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