Regulations undergo frequent changes, given by the continuous innovation in the health industry and the specific adaptations to the particularities of the countries in the region. The expertise of our regulatory affairs team enables you to navigate this dynamic landscape to ensure products conform to relevant regulatory requirements.
Over time, IPRAT has had fluid interactions with different regulatory agencies in the region such as ANMAT, COFEPRIS, ANVISA, AGEMED, INVIMA, ISPCH, ARCSA, among others, thanks to which it has formed an expertise that allows it to design optimal regulatory strategies. The outsourcing of regulatory affairs services has had a growing demand as it is a more efficient way of managing the regulatory strategy for pharmaceutical companies, either through total outsourcing or through the different contracting options that best suit their needs.
The services we offer is mainly intended for the registration of medical, pharmaceutical, cosmetic, food and dietary supplements products in Latin America:
Main Areas:
- Regulatory Context.
- Product Analysis and clasification.
- Dossier compilation and submission.
- Marketing Authorization Holding.
- Local Representation.
- Requirements.
- Labelling.
