We provide expert regulatory, clinical and compliance services to Pharmaceutical medical device manufacturers.

Our Services Include The Following:

• Preparation and submission of Regulatory documentation including
• Technical Files
• Design Dossiers
• Regulatory and Technical review and consulting
• Preparation and submission of registration for product applications
• Medical device vigilance and reporting systems
• Regulatory and manufacturing compliance
• Strategic and regulatory planning
• Regulatory/Quality GAP Analysis
• Interpretation of guidance documents and legislation
• Assistance with device labeling requirements
• Provide medical device classification