Services

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International Activities
Diligence
Start-up Services
Pre-Market Services
Manufacturing/Post-Market
Special Areas of Expertise

Overview of Regulatory Consulting Services

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International Regulatory Consulting and Services

• US FDA and Health Canada Agent and Correspondent Services
• Certificates to Foreign Govenments
• Remediation of Import/Export Detentions
  

Diligence

• Audit of Quality System, Design, and Regulatory Documentation
  

Start-up Regulatory Consulting and Services

• Regulatory Assessments and Strategies
• Sequential Quality System Development and Implementation
  

Pre-Market Regulatory Consulting and Services

• International Regulatory Strategy Development
• Pre-submission and Pre-IDE Meetings
• Design Controls
  
• Clinical Investigation and Evaluation
• Pre-Market Submissions
• Supplier Evaluations and Audits
• Electronic Submissions
  

Manufacturing and Post Market Consulting and Services

• Quality Systems Implementation and Auditing
  
• Crisis Management
• Manufacturer Registrations and Device Listings
  

Special Areas of Expertise

• Drugs and Combination Products
• Electronic Submissions
• Crisis Management
• Biocompatability
• Start-up Services