Latin America is still lacking regulatory harmonization that extends across its 20 member countries. There are some regional and sub-regional initiatives to promote regulatory convergence, but work is still ongoing and the stage of maturity of the regulatory system varies significantly from country to country. The region presents a challenge for global drug companies, leading to longer approval timelines and a bigger strain on resources. In order to succeed in LATAM the pharma industry must balance its global expertise and systems while addressing country specific requirements and regulatory nuances.
PharmaLex in the LATAM region operates using a mixed/combined model, with own offices in the regions most important markets, coupled/paired with a long-established partnership with an expert local service provider RAFINT (Regulatory Affairs International S.A.C.)*. Our partnership model ensures that PharmaLex can offer the full PharmaLex portfolio of products and services and using our central corporate operating system. This safeguards PharmaLex’s high-quality standards whilst at the same time enabling us to expand our products and services into new territories across the globe.
Covering countries including: Brazil, Mexico, Colombia, Peru, Argentina, Ecuador, Venezuela, Bolivia, Chile, Paraguay and Central American & Caribbean countries. PharmaLex LATAM has well-established local representatives with broad experience across the region. Their local expertise enables them to successfully navigate the regulatory landscape in each country, including significant experience in meeting with the local Health Authorities, such as DIGEMID (Peru) and COFEPRIS (Mexico).
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*RAFINT offers the core PharmaLex services specializing in regulatory affairs, including regulatory intelligence, maintenance, clinical trial applications and marketing authorization approvals. Supporting our existing LATAM operations, RAFINT seamlessly complements the PharmaLex portfolio offering our clients good value for money as well as confidence that their requirements will be met.
We are working with a number of large pharma companies and are looking to create a consortium of partners to collect feedback on expertise, availability and outcomes. If you would be interested in joining our consortium, please contact us on contact@pharmalex.com.
Rina and the team were brought in to help support us during the PMCPA complaint process and subsequent audits. Their expertise and approachability made this difficult process smooth. True professionals and a pleasure to work with!
Hard working and there when you need them
We really appreciate your responsiveness and availability during our previous exchanges and it is what we are waiting for from our partner.
In these unprecedented times, PharmaLex continues to support all clients by meeting virtually and providing experienced, remote-based consultants.
Biopharma Excellence is a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence – all under the PharmaLex brand. This global team of scientific, regulatory and commercial professionals provide strategic product development and proactive regulatory services to developers of biopharmaceuticals, cell and gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars.
