Recent legislation has increased the requirements and complexity for managing safety information for Pharmaceutical/Biotechnology companies as well as Dietary Supplement  manufacturers.  These changes WILL require you to re-evaluate your approach to safety information handling.

Safety Sells, Inc. can help you ensure that you are keeping patients safe and complying with all new laws.

On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendment Act of 2007(FDAAA) which amended the Federal Food, Drug, and Cosmetic Act.

This act added significantly to the power and authority of the United States Food and Drug Administration (FDA) to ensure the safety of medical products.  The  

December 22, 2006, President Bush signed the Dietary Supplement and Nonprescription Drug Consumer Protection Act into law.  This law amends the Federal Food, Drug, and Cosmetic Act and requires dietary supplement manufacturers to report serious adverse events to FDA within 15 business days of awareness.  The law also contains other requirements related to labeling, data archiving and other activities.  Compliance with the law is required within one year of the data of signature, thus supplement manufacturers have until December 22, 2007 to comply or be considered in violation of federal law.

Prior to the passage of this new legislation, the primary reference for regulation of the Dietary Supplement industry stemmed from the Dietary Supplement Health and Education Act of 1994, the first major legislation directed specifically at the Supplement industry. 

Safety Sells staff are well versed in the subtleties of these laws and Safety Sells Inc is prepared to assist medical products and dietary supplement manufacturers compling with all legislation related to safety information handling within their industry.

Let Safety Sells unlock the value of all products by demonstrating the conditions of use that result in superior safety of the products.  We can handle regulatory issues  and monitor the safety profile of all your products via a comprehensive set of services to ensure regulatory compliance and distinctive customer service.

We are experienced in handling sensitive safety information and have a proven track record of dealing with regulatory requests regarding product safety.  We will work with your marketing department to provide support that is aligned with the marketing philosophies of the firm.

Please contact us for a full analysis of how Safety Sells can help increase sales as well as decrease regulatory risk.

Services include:

• Product safety database hosting
• Advising, establishing, and managing outsourced relationships both onshore and offshore
• Product information services
• Safety signal detection
  • Using company data
  • Mining publicly available databases
• Designing and executing pharmacoepidemiology studies
• Product information/Product safety call center
• Adverse event reporting to FDA
• Aggregate report generation
• Product safety consulting
• Product development consulting
• Marketing research
• Product risk communication
• Training
  • Developing training programs
  • Developing content
  • Delivering company designed training