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Marketing Authorization Application & New Drug Application

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  • Marketing Authorization Application & New Drug Application

– Comprehensive advice on obtaining Health Registration.

– Document evaluation for compliance with local regulations prior to Health Registration application.

– Prepare, review, or modify labeling and advertisement material in compliance with local regulations.

– Prepare and File/Submit Health Registration.

– Application follow up until Health Registration is obtained.

–  Connect you to our local preferred distribution partners. 

Health Registration is similar to Marketing Authorization Application, Sanitary Registration Application, or a New Drug Application. The Health Registration is a document or certificate issued by the National Health Authority through its competent body, which is mandatory for all products for human use and consumption manufactured and/or marketed in the country.

Processed foods, food additives, medicines in general, Nutraceutical Products, Biological Products, natural processed products for medicinal use, homeopathic medicines and dental products; medical devices, biochemical and diagnostic reagents, hygienic products, pesticides for domestic and industrial use, manufactured in the national territory or abroad, for import, export, commercialization, dispensation and sale are subject to sanitary registration.

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