Corporate Summary

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

Corporate Summary: Supplement Safety Solutions

Mission

  • To help forward-thinking companies stay compliant, manage their risk, and distinguish themselves with a proactive safety-oriented approach to business that allows them to maximize product development and minimize safety risks
  • To provide business-savvy medical expertise that helps empower supplement companies to maximize product development and minimize liability / risk

Comprehensive Nutravigilance ™/ Supplement Surveillance Program

  • Comprehensive approach
  • From product development to formulation to product launch
  • Adverse event collection and risk-benefit assessment

Adverse Event Reporting

  • Expedited (mandatory) reporting to FDA for serious adverse events (SAE)
  • Narrative writing for voluntary reports
  • Clear, concise, accurate case description

Risk Management

  • Understand mechanism of action of products and key components
  • Identify key risks by product and discuss benefit-risk analysis with client

Business-Oriented Approach

  • Product safety is the first priority for product development and marketing
  • Helping clients attain financial success while focusing on product safety

Interaction with FDA

  • Prepare clients for FDA Inspection by identifying vital SOPs and documentation
  • Setting appropriate expectations with client executive leadership
  • Providing medical expertise as needed for direct interaction with inspectors

Professional Credibility

  • SSS has over 20 years of collective experience in the safety, dietary supplement and clinical research fields
  • Board certified physicians with specific experience in supplement safety

Training Employees on Relevant Standard Operating Procedures (SOPs)

  • Identify and help author clear, concise, SOPs in relevant areas of AE reporting and Product/Customer Complaints
  • Identify relevant employee groups for training, and conduct and document training

Cooperation with Legal Team When Necessary

  • Interact with client legal team, and provide medical expertise and medical interpretation of guidances and laws

Medical Monitoring

  • Serve as medical monitors on clinical studies
  • Protocol development and authoring of clinical study reports or publications

Product Nutravigilance TM Master File

  • Identification of key information to keep in one place, which facilitates recall and presentation in the event of an inspection

Web-Based Technology

  • SSS has developed a unique on-line form (The SAFER Form) to collect information on adverse events (AEs)
  • Form can be used by the RP on a real-time basis, or by the medical consultant

Strategic Business Needs

  • The founders of SSS have extensive experience in both medicine and business and recognize the need to attend to both.
  • SSS works with client companies to focus on product safety and to protect the brand

Flexible Agreements

  • Companies have different needs, and SSS offers a flexible, phased approach to enhancing the safety of your company
  • Phased-in approach recognizes that your main focus is to develop new supplements that distinguish you from your competition
  • As your company grows, services can expand to meet your needs

Clinical Research Organizations (CROs)

  • Working relationships with numerous contract research organizations (CROs) involved in research in dietary and nutritional supplements
  • Dr. Lopez is the Chief Medical Officer (CMO) for the Center for Applied Health Sciences, a CRO based in Ohio

Long-Term Professional Relationships

  • SSS intends to form long-term, mutually-beneficial relationships with ethical, hard-working companies

Strong Communication Skills

  • Proven ability to clearly communicate with regulatory agencies
  • Strong writing, speaking and interpersonal skills
  • Have made numerous professional presentations

 

Why is this service needed?

  1. Increased FDA scrutiny, number of inspections, and 483s issued
  2. 483 responses demand significant efforts (staff time and resources)
  3. Inadequate 483 responses lead to product recall
  4. Product recalls are costly and expose company to repeat inspections and competitive disadvantage
  5. Clear documentation of a proactive safety focus will decrease the likelihood of an inspection and enhance the Company’s relationship with FDA and other Regulatory bodies