Archives: Services
Clinical Strategy & Submissions
IDE, clinical protocols, ISO 14155 studies, real-world evidence.
LATAM Regulatory Strategy
ANVISA, COFEPRIS, INVIMA, ISP — bilingual project management.
Audit Readiness & CAPA
Mock FDA inspections, Notified Body audits, CAPA closure.
AI in MedTech Regulatory
FDA GMLP, PCCP, EU AI Act and ISO/IEC 42001 for AI/ML SaMD.
IND / NDA / BLA Submissions
eCTD authoring, publishing and FDA correspondence.
Pharma & Biotech Regulatory
INDs, NDAs, BLAs and global submissions.
Diagnostics & IVD Consulting
IVDs, LDTs, companion diagnostics — FDA & EU IVDR.
FDA QMSR Compliance
Transition from QSR (820) to harmonised QMSR by 2 Feb 2026.
ISO 13485 Consulting
Implementation, certification and transition to ISO 13485:2016.
Quality Management Systems
ISO 13485 / QMSR builds, remediations and harmonisation.
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