The Food and Drug Administration (FDA) in the US requires that all Dietary Supplements be regulated by the Dietary Supplements Health and Education Act of 1994. Manufacturers of the product must ensure that they make sure your products are safe and accurately labeled.
The FDA can take action against any manufacturer selling a product that appears to be adulterated or mislabelled.
It is the FDA’s responsibility to protect US citizens from unsafe products. It is the manufacturer’s responsibility to inform the FDA of any adverse events associated with their products.
The FDA also regulates the manufacturing practices of many products sold in the US. Current Good Manufacturing Practices (CGMP) are designed to ensure pharmaceuticals’ quality for humans in the US.
FDA compliance consultants help your company locate and complete the necessary documentation on the Safety Report Portal, as stipulated in section 761 of the Federal Food, Drug, and Cosmetic Act. Manufacturers and suppliers of dietary supplements are responsible for ensuring that supplements are safe and accurately labelled following DSHEA and FDA regulations.
Claims that products may have an impact on human health must be verified. They can help you review product labeling and health claims following FDA regulations.
Foreign manufacturers who wish to sell their dietary supplements in the US market must register with the FDA through a US FDA agent.
These agents act as intermediaries between the FDA and the manufacturer and are the first contact for FDA. They can provide a US agent service to any customer who wants to expand their business in the US market.
The advisor develops together with the counselee the documentation of the Management System. The advisor participates by reviewing the documents and activities created by the adviser who is responsible for the
FDA compliance consultants have offered comprehensive Consulting, Training, and Evaluation solutions to all types of companies in different countries of the continent, and based on experience, all clients seek the following:
• Better control and visualization of consulting projects.
• Less face-to-face consulting time and Greater commitment and better communication in all parties involved in the client’s organization.
• Turnkey documentation.
• Lower costs in travel expenses or transfer of external consultants.
After taking FDA compliance training, FDA compliance consultants understand that the food industry faces the enormous challenge of complying with legal and customer requirements.
They help you find solutions and implement new systems and schemes, adapting to your possibilities.
They have extensive food safety, social responsibility, organic certification, implementation of quality management systems, and resolves regulatory problems.
The consulting is a more effective solution to have a Management System always updated, functional, and with results in clients’ organizations.
TIME EFFECTIVE : With FDA compliance training, consulting, and remote management better focus time on planned topics, an hour of face-to-face or traditional consulting can be reduced by up to 35%.
FLEXIBILITY AND CONFIGURATION: What is possible to manage with FDA compliance training? They can configure and automate each project with multiple options to achieve what clients want.
BETTER COMMUNICATION: Direct communication with consultants at all times. They provide better internal communication and commitment to the Management System by the client’s management team.