Our Firm assists clients in securing the registration of their business with the Securities and Exchange Corporation (for corporations and partnerships) or with the Department of Trade and Industry (for sole proprietorships).
Our Firm assists clients in securing a License to Operate (LTO) and Certificates of Product Registration (CPR) from the Food and Drug Administration (FDA) and in complying with other regulatory issues in the FDA in an expeditious and cost-effective manner.
Establishments or entities intending to engage in the importation, exportation, distribution, and manufacture, and re-packing of products regulated by the FDA, must have a License to Operate prior to the start of its operations or for its continued operations. The processing of applications for the initial issuance, renewal or amendment of the License to Operate of establishments is referred to as Establishment Licensing.
All products distributed or sold by a licensed establishment must be registered with the FDA prior to their introduction in the local market and/or prior to their advertisement and promotion. The authorization to market is granted through the issuance of a Certificate of Product Registration (CPR) or Certificate of Notification (CON).
The processing of applications for the initial issuance, renewal or amendment of the marketing authorization is referred to as Product Registration.
Products regulated by the FDA fall under the following product classes: drugs, medical devices, diagnostic reagants, food, cosmetics and household hazardous substances.
