Food & Drug Administration Consulting
The FDA Philippines (Formerly the Bureau of Food and Drugs) was created under the Philippines Department of Health as the regulatory and enforcement organization for all food, drug, cosmetic, medical equipment, and related products. The FDA is responsible in ensuring the safety, purity, and quality of all products relating to; food, drugs, cosmetics, medical devices and household hazardous that are available in the Philippine market. The food and drug administration is tasked to regulate the production, sale and traffic of these products to protect the health and safety of the people.
The main functions of the FDA is to issue a License to Operate to establishments as importer /distributor / wholesaler / manufacturer for food, drug, cosmetics and medical devices with technical requirements in compliance to FDA Philippines regulation. All products to enter the market are issued a Certificate of Product Registration before it can be utilized in the Philippine market. The products must comply with technical requirements and recommend standards of identity, purity and quality set by the FDA.
The FDA is also responsible for the approval and monitoring of Clinical Trials in the Philippines. Companies wishing to introduce new and innovative products must first register with the FDA before being granted a temporary CPR for use during the clinical trial. This is a closely monitored process and regular reporting is necessary.
Triple i Consulting Pharma Division offers services for investors and entrepreneurs who wants to do business in the Philippines working with Food Industry, Cosmeceuticals and Pharmaceuticals. Triple i assists clients in processing and obtaining their License to Operate (LTO) as Importer, Distributor, Exporter or Manufacturer and approval of products to market here in the Philippines from the Food and Drug Administration.
- Orientation to our clients on the proper process and procedure in applying their company as well as their products with the FDA.
- Guidance in the preparation of documents to be submitted in the agency to avoid rejection and minimize submission of incomplete documents.
- Process and receipt of approval of application by thorough follow up and updates of application. In this way we monitor the application step by step.
Triple i Consulting has a team of pharmacists on staff to consult with FDA, one of the most stringent government offices in the Philippines. Contact Us to arrange an initial consultation with our Pharma Division.