Quality RA offers CMC, RA and QA services to the biotech. (e.g., ATMPs, vaccines, recombinant proteins, antibodies) & pharmaceutical industry (innovators, generics). Just a small selection of our services: - Providing advice on: development, validation and transfer of analytical procedures; setting up and reporting stability studies; justifications of specifications; comparability; risk assessments - Writing or review of CMC protocols and reports - Writing or review of regulatory submissions (Modules 2.3 and 3 of CTAs/INDs, Modules 2.3 and 3 of MAAs/BLAs, EU variations, scientific advice briefing documents) - CMC review and advice on regulatory strategy - Due diligence support - Interim CMC/QC/RA/QA colleague.