OUR OFFERING
Tailored regulatory consulting services for medicinal product developers worldwide.
EU Clinical Trials Regulation Compliance Support
Extensive hands-on expertise with Regulation (EU) no. 536/2014 (EU CTR) implementation and Clinical Trials Information System (CTIS) functionalities, since 2016.
Clinical Study Submissions
Advice on strategic regulatory questions for clinical trial applications, maintenance and reporting, as well as non-interventional clinical study submissions.
Trainings
Ruxandra is certified as EMA CTIS Sponsor Master Trainer and has a long track record in providing concise, clear and informative trainings to clinical trial sponsors and regulatory service providers.
EMA CPPs
Submission support for requests of EMA Certificates for Medicinal Products (EMA CPPs), as per the WHO Certification Scheme.
