Quality Ra

Quality RA offers CMC and RA services to biotech. & pharmaceutical companies, large and small. A selection of our services- Writing or review of regulatory submissions (Modules 2.3 and 3 of CTAs/INDs, MAAs/BLAs, EU/US post-approval change submissions, scientific advice briefing documents)- CMC review and advice on regulatory strategy - Gap assessments for submission readiness - Providing advice on: comparability; justifications of specifications; development, validation and transfer of analytical procedures; setting up and reporting stability studies, reference materials - Writing or review of CMC study protocols and reports - Due diligence support - Interim CMC/QC/RA roles