At Qserve, we take pride in our team of experts who support global registrations for medical devices in various countries. Today, we are pleased to introduce you to Gabriela Grozdanova Andonova, Global Registrations Specialist & Legal Counsel.
Gabriela joined Qserve in July 2024 as a Regulatory Affairs Associate in the Global Registrations team. Previously she worked for a Contract Research Organization, specialized in GI clinical trials, medical imagining, precision medicine and clinical consulting for pharmaceutical and biotechnology companies. She was acting as an interface between Clinical Operations and the Legal Department for contract requests and she was responsible for the day-to-day management of paper and electronic documents. Additionally, she contributed to the improvement of document management processes and systems.
Bringing Legal - and Linguistic Skills to the Team
Gabriela obtained her Bachelor of Laws degree with a major in Legal Studies in 2019 and Master of Laws degree in International Law and Relations and EU Law in 2021. Her master’s thesis focused on International Commercial Arbitration. She applied her theoretical knowledge in practice through an internship at a local law firm, where she reviewed and organized casefiles, pleadings and appeals while developing strong communication and time management skills.
Although based in the Netherlands, Gabriela has an extensive multilingual background, with proficiency in Macedonian (native speaker), English (professional), Serbian (professional), Croatian (professional), Bosnian (professional), Dutch (conversational), Bulgarian (conversational) and Russian (conversational).
Expertise You Can Rely On
Gabriela’s key areas of expertise are commercial arbitration and legal research, with a focus on practical application in contract management and regulatory compliance. Her tasks at Qserve consist of drafting, reviewing and monitoring the status of legal documents including contracts, agreements and compliance documents, as well as supporting negotiations and the execution of agreements. She also reviews and submits documentation for the registration of Medical Device and IVD manufacturers and their products for global market access, coordinating with clients to collect and compile all required registration documentation.
Gabriela is experienced in filing and maintaining site documentation in TMF for various clinical studies, with hands-on experience using Veeva Vault and strong knowledge of ICH-GCP guidelines.
Partner with Qserve for Your Global Registrations
In case you have any questions or want to know how we can support your business, please do not hesitate to reach out to the Qserve Global Registrations Department via globalreg@qservegroup.com