What we do:

Kamar Associates provides strategic regulatory consulting for companies navigating FDA and COFEPRIS requirements in the United States and Mexico. Our services include regulatory strategy, 510(k) support, drug and medical device regulatory guidance, label review, cross-border regulatory coordination, and strategic support for clinical trial pathways in Mexico in collaboration with a trusted local CRO.

For clients with broader or highly specialized needs we coordinate support through a trusted partner network of ex FDA and ex Cofepris agents offering expanded capabilities such as regulatory due diligence, FDA/COFEPRIS submissions support, audit preparation, drugs, medical device cybersecurity, ISO 27001 audit readiness, FSVP, and infant formula regulatory support. 

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