Committed to Patient Safety
We are dedicated to ensuring the safety, efficacy, and quality of healthcare products in the market by providing expert regulatory guidance and compliance support. Our commitment helps safeguard public health and reinforces trust in the industry.
Pharmacovigilance
We can function as your dedicated pharmacovigilance department, offering services such as the registration of your pharmacovigilance unit with the Comisión de Evidencia y Manejo de Riesgos (CEMAR) of the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). Additionally, we provide the pharmacovigilance officer (Responsable de farmacovigilancia) services, designating a professional to manage and oversee all associated activities, ensuring compliance and safety in your operations.
Technovigilance
Similarly, we can serve as your technovigilance department, assisting with the registration of your technovigilance unit with Comisión de Evidencia y Manejo de Riesgos (CEMAR) at Comisión Federal para la Protección contra Riesgos Sanitarios COFEPRIS. We also designate a responsible technovigilance officer to manage and supervise all relevant activities, ensuring compliance with safety standards and regulations in the medical device sector.
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