Sigrid Roosendaal

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

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Andrea Blok

Sr. CMC-RA/QA Consultant

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Sigrid Roosendaal's Contact Details

Email (Verified)
***@qualityra.nl

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Mobile Number
(XXX) XXX-XXXX

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Location
Driebergen-Rijsenburg,Utrecht,Netherlands

Company
Quality RA

Sigrid Roosendaal's Company Details

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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Sigrid Roosendaal currently works for Quality RA.

Sigrid Roosendaal's role at Quality RA is Sr. CMC/RA/QC Consultant.

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Sigrid Roosendaal works in the Research industry.

Sigrid Roosendaal's colleagues at Quality RA are Andrea Blok and others.

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