Quality RA

Quality RA offers CMC and RA services to the biotech. (recombinant proteins, ATMPs, monoclonal antibodies, viral vector vaccines) & pharmaceutical industry. Just a selection of our services: CMC: - advice on: development, validation and transfer of analytical procedures; setting up and reporting stability studies; comparability; process development and validation; risk assessments - writing of CMC protocols and reports - interim QC/QA colleague. Regulatory Affairs: - writing Modules 2.3 and 3 - preparing submissions (CTA/IND, MAA/BLA); EU variations; scientific advice briefing documents - CMC review and advice on regulatory strategy - due diligence support - interim RA colleague.