Amavita Sciences™

About Amavita Sciences™

Amavita Sciences™ is regulatory language infrastructure for Latin America. We deliver bilingual technical dossiers built to pass the first regulatory review — IEC 60601 test reports, ISO 13485 quality-plan documents, biocompatibility studies, Declarations of Conformity, and clinical protocols — for medical device, pharma, and biotech sponsors filing with INVIMA (Colombia), ANVISA (Brazil), COFEPRIS (Mexico), ANMAT (Argentina), DIGEMID (Peru), ARCSA (Ecuador), ISP (Chile), MINSA (Panama), and eight other LATAM regulators. Every deliverable ships in Bilingual Layout A: source page on the left, expert Spanish translation on the right, with source-referenced pagination, batch fingerprints (SHA-256), and a Certificate of Translation. Seven quality gates. Zero tolerance for source-pagination bleed into the translation. We are not a translation agency. We do not sell word-count. We do not offer "Traducción Oficial" — that is a separately regulated legal category in Colombia, Argentina, Brazil, Mexico, and Panama, and it is not what regulators need for a technical device dossier. Amavita Sciences™ is operated by IMH ASSETS CORP dba bioaccess®, an operator with 10+ years of hands-on LATAM regulatory clinical program experience. Learn more: amavitasciences.com