True North Synergy Inc.

West Vancouver, BC, Canada
Phone: (604) 922-1045
Fax: (604) 922-0282
Email: amancini@truenorthsynergy.com
Regulatory Affairs

Provides consulting services regarding:

  • Regulatory Approval Strategies
    • Regulatory approval strategies for the United States, European Union, Canada, other markets
    • Research regulatory case studies in relevant therapeutic indications
    • Meetings with health authorities to discuss development plans and approval strategies
  • Regulatory Affairs Operations
    • Briefing documents for meetings with health authorities
    • Applications to health authorities for initiation of clinical trials (INDs, CTAs)
    • Selection of contract research organizations or other contractors to complement internal team
    • Applications to health authorities for approval of new drugs
 

CTD Triangle