Dietary Supplements

Clinquest is a medical information and safety reporting center for the dietary/nutritional supplement industry offering customized services to meet the needs of your products and marketplace. Clinquest will provide the critical FDA-mandated GMP requirement for collecting, tracking and analyzing your complaints and safety events.

Your product will be assigned personnel trained to quickly and accurately obtain detailed information regarding a potential product quality issue and to determine if there is need for a safety event report or complaint investigation. The expertise, skills, and activities of our professionals facilitate your compliance with FDA requirements regarding manufacturing and product quality issues.

Core Activities:

  • Product Information Call Center
  • Product Complaints
  • Adverse Event reporting
  • Medical/consumer inquiries

Clinquest’s team of Specialists provides outstanding combined call center and product complaint & Adverse Event reporting triage services to meet our clients’ needs.

  • Dedicated Call Center
    • Toll-Free telephone number
    • Email account for receipt of information & follow-up and client & consumer/Health Care Professional correspondence
  • Single access point
    • Product Complaints
    • Product Information
    • Safety Event Reporting
    • Correspondence Management
  • Intake and handling of product and quality control complaints
    • Packaging
    • Expiration
    • Quality defects
  • Response generation and provision of peer-to-peer responses
    • Medical inquiries from consumers
    • Medical inquiries from health professionals
  • Detailed intake of information
    • Complainant name, address, phone number
    • Product name, strength, package size, lot number, expiration date
    • Availability of suspect product for retrieval
    • Acknowledge and track requests for product replacement, refund, or credit
  • Documentation of product complaints and consumer or health professional reports in Medical Information database
    • Tracking, appropriate reporting, and filing of all requests and Medical Information communications (maintaining consumer confidentiality)
    • Maintain official complaint and safety event file for client
    • Trend analysis of complaints for Quality Management Systems
    • Database links with FDA report form for Serious Adverse Event (SAE) reporting
  • Medical information and/or product review
  • Case processing for reportable AEs and SAEs
  • Notification of product complaints and safety event reports to clients

Additional Services

  • Response generation and provision of client-approved responses for inquiries from consumers and health professionals
  • Standardized Letter generation and provision
    • Additional information on product
    • Acknowledgement of receipt of complaint or safety event
    • Instructions to return product
  • Acknowledgement and tracking of requests for product replacement, refund or credit
  • Work with client to coordinate returns of suspected product
  • Provide and/or support Regulatory services in complaint and event reporting/tracking
  • Coordinate/Track complaint investigations and follow-up activities
  • Coordinate recall activities
  • SOP generation and training
  • FDA/EMA/MHRA Audit preparation and support
  • Regulatory reviews of Quality Control Systems

Clinquest can effectively provide these essential services to supplement your GMP Quality Assurance procedures in complaints and event tracking and reporting. We go beyond call center services and integrate directly with your GMP processes to assure compliance with the new regulations.