A cornerstone to CRO Group consulting is our focus on preventive compliance. It is far easier and less costly to instill good compliance practices than to react to a regulatory agency challenge or confrontation.
Regulated Industries ConsultingWe offer consulting services to companies in the medical device, biotechnology, and IVD industries to comply with FDA-QSR, Part 11, ISO 13485, Canadian MDR (CMDCAS), and EU MDD or IVDD regulations, and prepare product approval and licensing filings.
Notified Body/Registrar ConsultingWe offer related services to support European Notified Bodies, CMDCAS recognised registrars, as well as organisations and registrars intending to become Notified Bodies and CMDCAS registrars.
Software Manufacturer ConsultingWe offer consulting services for software manufacturers that wish to "break in" to the regulatedindustry market with related applications including that for auditing, defect analysis, ERP/MRP, document control, etc.