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Services for Latin America
We act as regulatory affairs experts for companies in the healthcare industry seeking to market their products in the Latin American market.
We offer our clients solutions for product registration, licensing, and brand, technology, and formulation protection, whether for cosmetics, medical devices, disinfectants, supplements, or medications.
REGULATORY STRATEGY
Depending on your projects and product types, we work to optimize your regulatory investment, reducing processes and reducing registration approval times.
REGULATORY GAP ANALYSIS
We perform a GAP analysis to anticipate the risks associated with the product to be registered and its technical dossier, as well as pre-registration documents and certifications.
PRODUCT REGISTRATION
Our technical teams support the health certification processes for cosmetics, medical devices, disinfectants, dietary supplements, sanitizing products, and medications.
HOSTING OF RECORDS AND REGULATORY LEGAL REPRESENTATION
Our technical teams and physical facilities are available to ensure accommodation, legal representation, and the maintenance of your health records.
HEALTH SURVEILLANCE
We carry out post-registration actions such as health surveillance, corrective actions applicable to registrations, and field actions when necessary.
GMP or CRO CERTIFICATION
Depending on local health legislation and the client's wishes, Mandala will provide a technical team of auditors to conduct a pre-audit in preparation for a visit by the country's health agency to the manufacturing site for GMP or the research site for ORC.
LABORATORY SERVICES
Acting as the holder of health licenses for medicines, we perform analytical method validations and quality testing in our own laboratory.
LEGAL SERVICES FOR COMPANIES
We advise you on setting up your branch and legalizing it under ANVISA regulations (AFE and expansion of activities). We offer administrative services such as legal representation and outsourced company administration.
REGULATORY DUE DILIGENCE
If you are looking to acquire a healthcare importer and/or distributor, Mandala has all the expertise necessary to assist you with the regulatory analysis of the target company.
MARKET RESEARCH
To help you define the best products for your business, we research relevant data on the industry, competition, and market situation.
SEARCH FOR DISTRIBUTORS
To facilitate your market access, we seek the ideal partners and distributors for your business in Latin America.
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