Regulatory Support

Real knowledge, real experience.

Leverage our in-country expertise when and where you need it. Our suite of regulatory services help you navigate regulatory requirements and plan for site success, at every stage of your product’s development.

Our unique network throughout Latin America provides leading in-country experts who understand the culture, nuance, and process of their country. This avoids delays and ensures your requirements are met.

Regulatory Services
  • Regulatory & ethics submissions support
  • GCP compliance auditing and training
  • Due diligence
  • Import/export licensure
  • Customs broker
U.S. & LATAM Regulatory Agencies
  • FDA (U.S.)
  • ANMAT (Argentina)
  • ANVISA (Brazil)
  • COFEPRIS (México)
  • INS (Perú)
  • INVIMA (Colombia)
  • ICGES (Panama)

Case Study

Client: Mid-Size Nutraceutical Company

Ask: Serve as authorized agent and regulatory representative in Central America, handle all logistics and licensure, and obtain all required regulatory and ethics committee approvals.

Situation: Central America provided the right population and a more cost effective research platform for the product candidate, but the company had never operated outside of the US.

PanAmerican Solution:  Identifying ambiguous regulations, PanAmerican sought to reduce costs and shorten timeframes by immediately engaging with governmental and ethics committee representatives to clarify and eliminate requirements. Simultaneously, PanAmerican engaged its in-country teams who provided weekly status reports and utmost transparency to the sponsor and sites, resulting in greater operational efficiency and compliance confidence. 

PanAmerican Result: The nutraceutical trial received all approvals in under the published timeframes and experienced no delays in importation.

PanAmerican combines FDA knowledge and compliance culture with an actual in-country understanding in Central and South America, giving us peace of mind when running FDA regulated trials in LATAM.