Mandala International, the key to your success inPeru!
WHAT WE DO
Mandala International aims at acting as a commercial and third partner on trust matters. Mandala will take care of the records of your products, provide the advisory service for applicable compliance certifications or laboratory tests for drugs), will be your legal regulatory representative in the country, it will guarantee the maintenance of your records and post-registration regulatory actions in compliance with applicable law (sanitary surveillance, technical and administrative modifications, renewal, …). In addition to being your partner in the certification of your products, Mandala will support you in the legalization processes of your company with the operating authorizations (Local sanitary license), as in the preparation of the quality management process. Thus, Mandala take care of regulatory and administrative requirements, while you remain independent and autonomous, and can choose your partners for marketing your products in the country.
It is necessary that products focused on the human health industry be registered by DIGEMID before going through any type of commercialization. Mandala is fully aware of the interpretation of the legislation, practices and requirements of Peruvian bodies to accompany you in the duly registration of the following: – Cosmetics; – Medical devices; – Sanitizing products; – Drugs; – Supplements. DIGEMID’S GENERAL GUIDELINES: – Registration needs to be required by a Peruvian company; – This company must have the sanitary licenses required by DIGEMID; – Registration or notification are withheld for a minimum of 5 years; – The registration or notification process takes between 3 to 6 months depending on the risk class applicable to your product.