Regulatory Affairs

Our team of regulatory experts helps you to overcome the challenges you will face due to the complexity of regulations in Mexico. We provide end-to-end regulatory services: from initial assessment, dossier preparation and submission up to approval and beyond, including the entire range of post-marketing services.

You will benefit from our broad technical expertise and indepth knowledge of local regulations regarding:

• Market access consulting.
• Registration of New Molecules and Generics (allopathic, biotechnological, biological, vitamins, herbals, homeopathic,...)
• Registration of Medical Devices classes l,ll,lll.
• Registration of Food Supplements.
• Registration of Cosmetics.

Hosting

We can act as your legal representative for your products on behalf of your company with the local competent authorities.

Hosting Services include:

• Up Pharma being the registration holder.
• All necessary notifications to authorities.
• Services of our Sanitary Responsible.
• All administrative activities to maintain current the
• marketing authorization for your products in Mexico.

Pharmacovigilance and medical devices post-market suveillance (technovigilance)

• Development of Risk Management Plan.
• Post Marketing suveillance: Periodic Safety Update Report.
• Development and implementation of the Quality Assurance System for
• pharmacovigilance.
• Development and implementation of the Quality Assurance System for Post
• Marketing suveillance of medical devices (technovigilance).
• Reception and follow-up of case reports of adverse drug reactions
• and case reports of adverse incidents.
• National and international scientific literature search.
• Signal detection in pharmacovigilance.
• Final report of pharmacovigilance and final report of post-
• marketing security (technovigilance) for medical devices -
• requiered for renewal of Marketing Authorization.

Supply Chain

We deliver your products to wholesalers, hospitals, clinics and pharmacy chains across Mexico. Our modern facilities and fleet are professionally managed and subject to the most stringent international quality requirements, notably ISO 9001, Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).

• Trade procedures.
• Import and export management.
• Customs management.
• Logistics.
• Warehousing and physical distribution.