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Pharma & Biotech Regulatory
INDs, NDAs, BLAs and global submissions.
IND / NDA / BLA Submissions
eCTD authoring, publishing and FDA correspondence.
AI in MedTech Regulatory
FDA GMLP, PCCP, EU AI Act and ISO/IEC 42001 for AI/ML SaMD.
Audit Readiness & CAPA
Mock FDA inspections, Notified Body audits, CAPA closure.
LATAM Regulatory Strategy
ANVISA, COFEPRIS, INVIMA, ISP — bilingual project management.
Clinical Strategy & Submissions
IDE, clinical protocols, ISO 14155 studies, real-world evidence.
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