Quality RA
Research - Leiden, South Holland, Netherlands
Quality RA Employees
Quality RA Details
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.
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