Services: Regulatory

From senior executive counsel to highly detailed task work, Alquest develops and executes regulatory strategies for manufacturers of medical devices including IVDs (in vitro diagnostics), biologics and combination products.

How We Work

Alquest provides regulatory support in multiple ways:

ad hoc hourly consultation and advice
Submission support
Functioning as a virtual Reg/QA department
Emergency response to Agency concerns, warnings or decisions
Onsite staffing (Minneapolis and San Francisco)

Common Assignments

Regulatory assessment
Pre-IDE meeting preparation, including development of FDA information packet
Pre-IDE meeting participation
Pre-Market Submissions: 510(k)/PMA/BLA
FDA field inspection preparation support
FDA advisory panel preparation and meeting support

Other Needs

Through the years, Alquest has supported hundreds of clients seeking regulatory designations, clearances and international registrations. Our other services include:

Strategy Planning
Agency Interaction
Device Classification/Predicate Device Searches
Product Modification Strategies and Management
Import/Export Requirements and Management
Labeling/Advertising Review Strategy
FDA Collaboration Meetings Real-Time Reviews Regulatory Submissions
International Registrations/Submissions
Device Listing and Establishment Registration
Regulatory File Letters
Create Technical Files
Post-Market Support
Recall Planning and Management
Medical Device Reporting/Complaint Handling
Warning Letter Resolution
Inspection Advice and Management
Quality Systems Training — Individual or Small Group, Management or Production
Audit Preparation Other Regulatory Capabilities
Assist FDA in communications with a foreign establishment
Respond to questions regarding the foreign establishment's products
Assist FDA in scheduling inspections of foreign establishments
Technical Papers and Abstracts
Literature Searches and Bibliographies
Write and Develop SOPs and Manuals
Annual Progress Reports