Supplement Safety Solutions
Supplement Safety Solutions provides expert consulting services to Nutritional and Dietary Supplement companies by focusing on safety, compliance, and risk management.
Our dictum is:
“Bringing new supplements to the marketplace is your business. Keeping them safe and protecting your brand is ours.”
We strive to provide you the consumer and the manufacturer of supplements with the latest information on safety and recalls. We also provide specific information about supplements to the FDA as submitted by consumers using our Adverse Event form.
Below is a sample of our services:
- Effective Implementation of Comprehensive Nutravigilance ™/ Supplement Surveillance Program
- Perform Adverse Event reporting, compliance and management
- Provide critical elements of a company’s risk management platform
- Business-oriented medical consultation, safety assurances that can be leveraged in marketing
- Safeguards for effective interaction with FDA and other regulatory bodies (i.e., Audit/ Inspection Readiness)
- Professional credibility, discretion and confidentiality
- Develop and train employees on relevant SOPs (competency & compliance)
- Cooperation with Legal Team when necessary
- Medical monitoring oversight on clinical studies, and product design
How are we unique?
- Specific Medical Expertise: >20 years of collective relevant experience with safety, dietary and sports supplements, clinical trials
- Implementation of our “Comprehensive Nutravigilance ™ / Supplement Surveillance Program”
- Product Nutravigilance ™ Master File "organizational data, product safety data, with statistical analysis and algorithm to identify risk:benefit ratios and safety patterns within a product line"
- Use of web-based technology to enhance ease of AE reporting
- Strong understanding of strategic business needs and regulatory requirements
- Flexible, cost-effective consulting agreements and services
- Network of clinical research organizations and laboratories to perform high-quality clinical research using GCP-ICH guidelines for safety, efficacy and claim substantiation/validation
- Desire for mutually-beneficial long-term professional relationships
- Strong communication skills