Lifecycle Management

The Latin American pharmaceutical market is changing.

In the past decade, new drug patent laws and increased regulatory pressure in areas like bioequivalence certification, product data protection, and supplier certification have had significant impacts across the region.

Additionally, regulatory authorities have started to demand new clinical studies to gather more information about the safety and efficacy of registered drugs and the rationale behind certain therapeutic associations. This new environment has left market leaders struggling to adapt. Regulatory uncertainty regarding the registration of biosimilars hasn’t helped. Major players in this industry have seen their registrations in Latin America fail due to their lack of understanding of local agency requirements and issues such as poor dossier translation and assembly.

In the midst of this changing landscape, opportunities abound in the region. Pharmaceutical companies from highly regulated marketplaces that wish to expand their product lifecycles by registering or improving existing formulations, searching for new indications, opening new markets or developing API combinations and technologies that synergize product efficacy and safety have the advantage. These companies simply need an experienced local partner who can guide them through the complexities of each market in order to achieve their goals. They need Pkinetix.

Pkinetix provides customer-centric lifecycle management services that offer customized, cost-effective solutions to drug companies seeking to expand into Latin American markets. We offer a nuanced understanding of local regulatory frameworks, service offerings, and market sizes as well as local prescription and consumption habits. Our experience is critical to maximizing your company’s business potential in the region.