QualityCR: Your Trusted Partner in Pharmaceutical Excellence
QualityCR, headquartered in the Netherlands, is your go-to independent consultancy firm. We are committed to serving a diverse clientele, including pharmaceutical companies, governmental institutions, research-oriented organizations, and clinical trial sites. Our expertise lies in the enhancement of Good Clinical and Good Manufacturing Practices.
What we bring to the table:
- Independent Quality Assurance advice in GCP and GMP: our dedicated team ensures your operations meet the highest quality standards.
- Risk Management Consultancy: Mitigate risks effectively, securing your projects.
- Internal and externala uditing
- Inspection readiness
Elevate Your Clinical Trials with Our Outstanding Services
Experience Quality Assurance (QA) like never before with our tailored approach to meet your business needs. We specialize in getting you inspection-ready and offer both in-house and online GMP and GCP training solutions.
Our audits are designed to supercharge the quality of your clinical trials, ensuring you're well-prepared for regulatory inspections and third-party audits.
We have a special focus on regions that urgently require support in quality, risk management, and inspection readiness, whether it's in the dynamic landscape of Europe or beyond. At QualityCR, we are your dedicated partner in elevating the standards of pharmaceutical manufacturing and clinical research.
The results? Your team will enjoy enhanced outcomes, reduced time investments, and streamlined processes that cut costs by eliminating waste. Partner with us to achieve clinical excellence.
Daniela van 't Ent is the founder of QualityCR. Her academic journey, professional experience, and commitment to quality sets her apart as a trusted partner in your clinical research endeavors.
Daniela's academic prowess is the cornerstone of her expertise. She holds a Bachelor's degree in Biochemistry, a Master's degree in Biotechnology, and a Ph.D. in Medical Sciences earned at Radboud University Medical Center in Nijmegen, The Netherlands.
As a scientist, Daniela has embarked on a transformative journey, gaining experience in prestigious research institutes and pharmaceutical companies such as Janssen Vaccines and Prevention Center in Leiden, Roche Diagnostics GmbH in München, Institute of Polymer Research at GKSS Research Center in Berlin, National Institute of Research Agronomique in Paris and several other pharmaceutical companies and CROs in the Netherlands.
Daniela's journey extended into the Good Manufacturing Practice (GMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GCP). Her contributions in the manufacturing of sterile and non-sterile vaccines and medical radionuclear isotopes at HAL Allergy and Mallinckrodt Pharmaceuticals have broadened her expertise, particularly in understanding the challenges of Investigational Medicinal Product (IMP) production processes. Her diverse exposure has enhanced her skills and insights.
In response to the escalating importance of quality and risk management in clinical research, Daniela founded QualityCR in 2020. Her passion lies in guiding scientific personnel, physicians, and nurses to conduct high-quality and compliant clinical studies while advocating for quality standards in day-to-day IMP production processes. She has partnered with both Sponsors and Contract Research Organizations (CROs), conducting numerous GxP audits and delivering QA advice and compliance. Her passion for learning and contributing to diverse projects fuels her motivation and expertise.
Your Advocate for Quality and Compliance
By choosing QualityCR you are gaining a dedicated advocate for quality and compliance in clinical research.