Regulatory & Quality Compliance

For more than a decade, the regulatory professionals at BioQuest have been successfully navigating the tricky and ever-changing waters of the technical and regulatory landscape.  We will coordinate implementation of actions to ensure your goals are achieved — both efficiently and economically.

Operational Review
Count on BioQuest to help you with any of these operational areas.

• 510(k) & PMA and BLA Submissions
• FDA Vulnerability and Risk Analysis
• Equipment, Facility, & Software Assessment and Validation
• Vendor & OEM Audits
• Design Control
• Sterility Validation
• ISO 9000 & EN46000 Pre-Assessment Baseline Audits
• Statistical Process Controls
• EU Submissions & Registrations
• BioStatistics
• Process Validation
• Reliability, Manufacturing, & Maintainability
• Product Development Planning and Management

Issues Management
Our experienced professionals will quickly grasp your situation and goals, and will work closely with your staff in formulating a resolution.  We have a solid track record of providing resolution with FDA compliance and validation issues, including the following:

• Agency Representation & Negotiation
• Recalls, Field Corrections & Safety Alerts
• Warning Letter Responses
• Compliance Certification
• Clinical Trials
• Complaint Management and Reporting
• Post Market Surveillance and Reporting
• FDA 483 Responses
• Corrective Action Programs & Management
• Import Alert & Detention Removal Programs
• Consent Decree Programs