Regulatory dossier development & review: IMPD, IND, IB, BLA for ATMP and Biologics.

Regulatory dossier development & review: IMPD, IND, IB, BLA for ATMP and Biologics.

Inspection readiness (EMA & FDA): gap assessments, mock inspections, targeted training, logistics planning, storyboards, and white papers.

Supplier & subcontractor audits: qualification, performance monitoring, and remediation plans

Inspection readiness (EMA & FDA): gap assessments, mock inspections, targeted training, logistics planning, storyboards, and white papers.

Supplier & subcontractor audits: qualification, performance monitoring, and remediation plans

We operate nationally and internationally with integrated solutions and cross-disciplinary expertise.