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Regulatory Affairs

O

ur expert team made up of law, pharmaceutical and veterinary professionals will help you navigate the cumbersome process of obtaining marketing authorization in Nicaragua.

Our regulatory team keeps abreast of regulations that change frequently due to legal, economic and even political reasons, and will provide you accurate information on required documents and samples.

Once the required documentation has been received we thoroughly review and assess the dossier in order to assure its completeness and to avoid actions from the regulatory authorities, which result in delays that may have a negative impact on sales.

Our services include obtaining marketing authorization of pharmaceutical, veterinary and chemical products, drafting and reviewing distribution agreements, pricing regulations, compulsory and voluntary licensing, and general regulatory issues.

Bendaña & Bendaña’s clients include a number of multinational and local pharmaceutical companies.

Services

• Marketing authorization of pharmaceutical, veterinary and chemical products
• General regulatory issues
• Product registrations
• Compulsory/voluntary licensing
• Pricing regulations
• Distribution agreements

Our team includes lawyers and qualified pharmaceutical and veterinary doctors.

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