USA

The United States Food & Drug Administration (FDA) is a dynamic and ever-changing regulatory landscape, which can be daunting for MedTech companies. As a leading regulatory, clinical and compliance advisor, Accel Group’s team of FDA expert consultants specializes in U.S. market access, with a focus on FDA submission and CRO.

Our Comprehensive Services:

Regulatory Services:

• FDA Regulatory Strategy
• Q-Submission (Q-Sub)/Pre-Submission (Pre-Sub)
• 513(g) Requests for Classification
• De Novo Requests
• 510(k) Submissions 
• PMA submissions 
• Investigational Device Exemptions (IDEs)
• Breakthrough Device Designation Requests
• Emergency Use Authorizations (EUA)
• Humanitarian Device Exemption (HDE)
• Accessory Classification Request
• Dual 510(k) + (CLIA) Waiver
• CW (CLIA Waiver) Submission
• FDA Meetings – Various Informational Meetings
• Advertising and Promotion
• Labelling
• Training
• UDI and GUDID

CRO Services:

• Clinical Strategy Development
• Clinical Evaluation Report (CER)
• Medical Writing and Document Development
• GCP Compliance
• Clinical Study Design and Implementation
• Site-selection and Qualification
• EC approval
• Clinical Trial Initiation
• Patient Recruitment
• Data collection, Management and Statistics
• Site management and monitoring
• Quality assurance
• PMCF Study

FDA QMS Implementation

• Design Review
• Complete QMS Setup and Review – 21 CFR Part 820
• Gap Assessment 
• Internal Audit and Mock Inspection

FDA Post Market Surveillance

• Postmarket Requirements 
• FDA eMDR Adverse Event Reporting
• Recall
• Corrective Action Preventive Action (CAPA) Support
• Design Change
• US Agent
• Registration and Listing