Andrea Blok

Sr. CMC-RA/QA Consultant at Quality RA - Leiden, South Holland, Netherlands

Andrea Blok's Colleagues at Quality RA
Sigrid Roosendaal

Sr. CMC/RA/QC Consultant

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Email (Verified)
***@qualityra.nl
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(XXX) XXX-XXXX
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HQ
Location
Leiderdorp,Zuid-Holland,Netherlands
Company
Quality RA
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Quality RA

Leiden, South Holland, Netherlands • 5 Employees
Research

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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Andrea Blok currently works for Quality RA.
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Andrea Blok works in the Research industry.
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