Maintaining Compliance Every Step of The Way

Without ensuring all Regulatory Aspects are appropriately handled, all of the diligent work in developing and planning a trial will be wasted.  

ClinSmart keeps compliance at each step of a project regardless of whether our Regulatory Services are being engaged on a project or not.  

We are ready to work with your team to analyze the regulatory aspects of your upcoming project. 

Compliance services ClinSmart provides includes:

  • Acting as a regulatory agent with FDA on your behalf 
  • Develop and/or review Regulatory Strategies 
  • Organizing pre-IND and Pre-NDA meetings and submissions  
  • Prepare eCTD and review submissions to the FDA and electronically submit them through FDA’s ESG. 
  • Coordinating special FDA meetings including End of Phase II meetings and Special Protocol Assessments as may be required 
  • Auditing for pre-approval inspections and general cGxP compliance for clinical sites, manufacturing sites, and packaging sites
  • Overseeing QA review and release of all data  

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