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
Company Details
- Employees
- 3
- Founded
- 2006
- Address
- Leiden, Zh, Nl
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Website
- qualityra.nl
- Keywords
- CMC RA, Submission co-ordination, CMC writing.
- HQ
- Leiden, ZH
- Competitors
- Xendo, Protinhi Therapeutics, Triskel Integrated Services, Swiss Personalized Health Network (SPHN), Central Committee on Research Involving Human Subjects (CCMO), SFL is now Veristat, Timmers Food Creations, Netwerk Divers Vakmanschap (Politie), Proxy Services B.V., BVL | Business Vereniging Leiden.
Quality Ra Questions
Quality Ra's website is qualityra.nl
Quality Ra's LinkedIn profile is https://nl.linkedin.com/company/quality-ra
Quality Ra has
3 employees.
View email and phone details for 3
employees at Quality Ra.
Quality Ra's industry is
Biotechnology Research
Quality Ra's top competitors are
Xendo,
Protinhi Therapeutics,
Triskel Integrated Services,
Swiss Personalized Health Network (Sphn),
Central Committee On Research Involving Human Subjects (Ccmo),
Sfl Is Now Veristat,
Timmers Food Creations,
Netwerk Divers Vakmanschap (Politie),
Proxy Services B.v.,
Bvl | Business Vereniging Leiden.
Quality Ra's categories are Biotechnology Research
Quality Ra's founding year is 2006
