Regulatory

LATAM Regulatory Strategy

ANVISA, COFEPRIS, INVIMA, ISP — bilingual project management.

Representative work

Device classes & artefacts we support.

Flags from many countries
Flags from many countries
LATAM Strategy ANVISA
LATAM Strategy ANVISA
Diagnostic instrumentation
Diagnostic instrumentation
Combination product packaging
Combination product packaging

The problem

Latin American Authorities require different specifications (BPF, GMP, country-specific INFARMED); native Spanish & Portuguese speaking consultants may miss key nuances due to only providing services in English.

Our solution

Development of regulatory strategies for Latin America: Spanish-speaking countries include Dominican Republic, Colombia, Costa Rica, Mexico, and other South American Countries, while Brazil speaks primarily in Portuguese.

Process

How we run this engagement.

  1. Market & regulatory mapping

  2. Local representative agency strategy

  3. Submission authoring (PT / ES / EN)

  4. Authority interaction & inspection support

  5. Post-market reporting harmonization

ANVISA, COFEPRIS, INVIMA, ISP — bilingual project management.

How we help

Native Spanish & Portuguese regulatory strategy across Mexico, Brazil, Colombia, Argentina, Chile and Peru.

Category

Global Markets

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