Services

121 Davis Road
Bedford, MA 01730
Phone: 781-835-9222

Supplement Safety Solutions - Services

What Do We Do?

Adverse Event Collection and Analysis

  • Secure, user-friendly web-based AE questionnaire
  • 800# staffed by live person, who will take down contact information for a reporter, and send to HCP at Supplement Safety Solutions (for follow-up on case)
  • Interact with users and health care professionals to obtain accurate information about a case

 

FDA Interaction

  • Serve as Responsible Person for collection, analysis and submission of MedWatch 3500 and 3500A forms to FDA
  • Interact with FDA as needed (phone, in writing, face-to-face, response to audit)
  • Prepare company employees for an FDA audit

 

Training

  • Good Clinical Practices (GCP) training and consulting: in person and/or web-based
  • Good Manufacturing Practices (GMP) and US Pharmacopoia (USP) training and consulting
  • Development of Standard Operating Procedures (SOPs) for clinical, manufacturing and safety-related topics
  • Employee responsibilities in safety reporting and Audit Response

 

Risk Analysis

  • Perform Risk Assessment of current supplement portfolio (i.e., analyze potential for problems based on components in supplements)
  • Review design and implementation of Phase I protocols or Phase I safety results
  • Review current labeling for adherence to FDA Guidance

 

Other Services

  • Write educational and labeling material
  • Monthly literature search for AE reports and competitive information
  • Annual Reports to FDA