Regulatory Affairs Services

– Regulatory Strategy Consultation

– Gap Analysis

– Preparation and Submission of Regulatory Documents

– Regulatory Agency Meetings and Communications

– Regulatory Project Management 

– Leading PI Recruitment

– US Agent Representation

– 510(k)
– Clinical Laboratory Improvement Amendments (CLIA) Waiver
– De novo Submission
– Investigational Device Exemption (IDE)
– Premarket Approval (PMA)  

– US Agent Representation