Mandala International, the key to your international success.
Reference in product regularization in Latin America
ABOUT US
MANDALA INTERNATIONAL
With over 15 years of experience in business development, Mandala International has become a reference in regulatory services in Latin America. We act on regulatory matters for companies in the health industry, seeking to market their products in the Latin American market.
We provide our customers with solutions to register products, host licenses, protect brand, technologies and formulas, for cosmetics, correlates, sanitizing products, food complement, or drugs.
Make health products accessible as many people as possible in Latin America and Central America.
Become a trusted partner of all manufacturers and distributors who want to develop in Central America and Latin America.
- QUALITY AND HONESTY: Strive to do, as best as possible, a honest, and serious work without compromising our integrity.
- EXCELLENCE WITH SIMPLICITY: Each client is important and should have a quick and proper response.
- FRATERNAL: Remain a company on a human scale where each individual is important.
WHAT WE DO
OUR SERVICES
REGULATORY STRATEGY
According to your projects and type of products, we operate to optimize your regulatory investment, considering the reduction of processes and the approval time of the registrations.
REGULATORY GAP ANALYSIS
We performed a GAP Analysis to anticipate product-related risks to be registered and its technical dossier, as well as documents and prior registration certifications.
PRODUCT REGISTRATION
Our technical teams follow the processes of sanitary certifications of cosmetics, correlates, food complements, sanitizing products and drugs.
REGISTRATION HOSTING AND LEGAL REGULATORY REPRESENTATION
Our technical teams and physical structures are available to ensure lodging, regulatory legal representation and maintenance of their sanitary registrations.
SANITARY SURVEILLANCE
We carry out post-registration actions such as: Sanitary Surveillance; corrective actions applicable to the registrations; and field actions when necessary.
GMP OR CRO CERTIFICATION
According to each local health legislation and the customer’s will, Mandala shall provide an audit technical team to perform an audit preparation previous to the visit of the health agency of the country where the manufacture occurs for GMP purposes, or where the research occurs for CRO purposes.
LABORATORY SERVICES
Acting as a holder of the health licenses of drugs, we perform the validations of the methods of analysis and quality tests in its own laboratory.
ENTERPRISE LEGAL SERVICES
We advise you on the establishment of your branch and the duly enforcement and compliance with Anvisa's standards (AFE and expansion of activities). We offer administrative services such as legal representation and outsourced management of the company.
REGULATORY DUE DILIGENCE
If you want to acquire a company that imports and/or distributes health products, Mandala has all the necessary knowledge to accompany you in the previous regulatory analysis of the company, target of the purchase.
MARKET RESEARCH
To assist in defining the best products for your business, we seek relevant data on industry, competition and market situation.
SEARCH FOR DISTRIBUTORS
To facilitate your market access, we seek ideal partners and distributors for your business in Latin America.
WHO WE DO IT FOR
SECTORS WE SERVE
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