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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

  • Specialized advice for dossier documentation

  • Constant review for an efficient and responsible submission of your product

  • Obtaining records in a timely manner

  • Defining strategy and supporting answers to Deficiency Letters

  • Management of the life cycle of your records before Cofepris

  • Compliance with standards in text development, label projects and graphic design

  • Advice on pharmacovigilance

  • Successfully obtaining MA approvals

  • Procedures manuals according to the standard

  • Documents traduction

  • Administration of import permits and customs administration

  • Legal support

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