The Technological University Dublin Pharmaceutical Regulatory Science Team (PRST) was founded in 2005 in response to the drive for a paradigm shift towards more science and risk-based approaches to ensure pharmaceutical product quality.
PRST actively engages with global industry and regulators to address the challenges and opportunities of implementing Science and Risk based decision making and manufacturing approaches.
PRST research emphasis is on the development of patient-focused strategies, frameworks, models and tools to enable those involved in the manufacture of drug products to meet the evolving international regulatory expectations ensuring the availability of high-quality medicinal products.
Company Details
- Founded
- 2005
- Address
- Tu Dublin Grangegorman, Dublin,ireland
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- https://www.prst.ie
- Keywords
- post-approval changes, pharmaceutical regulation, risk-based decision-making (RBDM), quality risk management (QRM), knowledge management (KM), ICH Q10, ICH Q9, pharmaceutical quality system, systems thinking, operational excellence, pharmaceutical manufacturing, validation, regulatory science, ICH Q12.
- HQ
- Dublin
Pharmaceutical Regulatory Science Team Questions
Pharmaceutical Regulatory Science Team's website is https://www.prst.ie
Pharmaceutical Regulatory Science Team's LinkedIn profile is https://ie.linkedin.com/company/prst-ie
Pharmaceutical Regulatory Science Team's industry is
Pharmaceutical Manufacturing
Pharmaceutical Regulatory Science Team's top competitors are
Teva Pharmaceuticals,
Novartis,
Pharmaceutical Regulatory Services, Inc.,
Biomarin Pharmaceutical Inc.,
Clearsight Digital Forensics,
Bristol Myers Squibb,
Pharmaceutical Manufacturing Technology Centre,
Pharma International Company,
Manking,
Pharmaceutical Raw Material.
Pharmaceutical Regulatory Science Team's categories are Pharmaceutical Manufacturing
Pharmaceutical Regulatory Science Team's founding year is 2005
