Local and global regulatory expertise

icon_Scope_Regulatory_Affairs

REGULATORY AFFAIRS

Bringing a new product from development to marketing approval is an expensive and lengthy process. If unanticipated delays occur, costs in both time and money can rapidly escalate. SCOPE provides full regulatory support for clinical studies (clinical trials as well as non-interventional studies (NIS

Our project managers work closely with our regulatory affairs department to ensure all areas of your clinical study meet international and local regulatory standards.

Thorough but fast, our regulatory experts cut out delays and help reduce costs.

  • Advice on regulatory procedures for clinical studies at any stage in the process.

  • Preparation and submission of initial applications and substantial modifications under involvement of our local study teams

  • Local accompanying of the approval process and communication with competent authorities as well as ECs / IRBs and other parties

  • Reporting, notification for information during and after the clinical study (non-safety and safety via Pharmacovigilance)

  • Reporting, notification for information during and after the clinical study

  • Import / export licenses (incl. narcotics and psychotropic drugs)

  • Support in entering information in registry platforms and databases (incl. result disclosure)

For expert guidance on regulatory affairs:

CONTACT US