Quality RA
Company

Quality RA

Biotechnology Research Leiden, Zuid-holland, Nl 3 employees
Employees
3
Contacts
1
Emails
1

Quality RA Overview

Headquarters
Leiden, Zuid-holland, Nl
Website
qualityra.nl
Industry
Biotechnology Research
Employees
3
Founded
2006
NAICS
Research and Development in Biotechnology (except Nanobiotechnology)

About Quality RA

Quality RA offers CMC and RA services to biotech. & pharmaceutical companies, large and small. A selection of our services: - Writing or review of regulatory submissions (Modules 2.3 and 3 of CTAs/INDs, MAAs/BLAs, EU/US post-approval change submissions, scientific advice briefing documents) - CMC review and advice on regulatory strategy - Gap assessments for submission readiness - Providing advice on: comparability; justifications of specifications; development, validation and transfer of analytical procedures; setting up and reporting stability studies, reference materials - Writing or review of CMC study protocols and reports - Due diligence support - Interim CMC/QC/RA roles

Quality RA Contact Details

People in AeroLeads
2
With contact data
1
Email contacts
1
50.0% coverage

Quality RA Org Chart

Sample employees and titles
Name Title Contact
Liane Schep Administratief Medewerker Bij Globel
View
Edo Van Der Kemp
Email

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