
Regulatory Processes
CODENSA
One step ahead
CODENSA provides extensive know-how and experience , supporting companies with the regulatory strategy and management of the Mexican filing process until MA approvals, tendering, marketing and sales, as well as distribution in Mexico.
Tailor-made services for companies oriented to the production of pharmaceutical products, consisting of:
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Regulatory strategy
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Specialized advice for dossier documentation
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Constant review for an efficient and responsible submission of your product
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Obtaining records in a timely manner
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Defining strategy and supporting answers to Deficiency Letters
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Management of the life cycle of your records before Cofepris
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Compliance with standards in text development, label projects and graphic design
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Advice on pharmacovigilance
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Successfully obtaining MA approvals
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Procedures manuals according to the standard
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Documents traduction
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Administration of import permits and customs administration
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Legal support