Who we are
At Med-Clinical, we provide a comprehensive suite of services dedicated to guiding healthcare companies in all departments from market access to marketing and also through the intricate process of achieving CE marking. Founded with a commitment to excellence in 2021, our team, strives to assist various stakeholders within the healthcare sector in navigating the complexities of a highly regulated industry. Our primary focus lies in aiding medical device, in-vitro diagnostic, and drug innovators to adopt a practical and rational approach in fulfilling legal obligations. Med-Clinical was established with a mission to make a meaningful impact, ensuring that patients receive access to safe and effective devices in a timely manner.
Our team
Executive department
Mikaela Dimitriu - Chief Operating and Commercial Officer
25 years experience in management: clinical development, medical affairs, biometry, health economics, patient engagement, regulatory and manufacturing.
A strong track in managing and leading cross-cultural and cross-functional global teams in complex situations.
Background training in science with extensive management experience at executive level.
Typhaine Favre-Gommard - Chief Administrative and Finance Officer
Strong Experience in the HR Department and Finance.
Expertise in Marketing and Social Networks.
Worked in various sector as Executive Research Company, Industrial, Consulting Services and Pharmaceuticals Companies.
Clinical department
Audrey Serpault - Clinical Project Manager
Strong experience in the clinical research organizations: clinical and project management.
Operational manager.
Hospital pharmacy preparer.
Valérie Longin - Clinical Project Manager
10 years of experience in healthcare, expertise in clinical research, pharmacovigilance and excellent relationship with the various stakeholders.
CRA for interventional studies and real life studies in different therapeutic areas.
Good Clinical Practices (GCP), Sites selection, Regulatory submission, Monitoring activities.
Zsofia Czinege - Biostatistician and Data Junior Manager
Various experiences in biostatistics.
End of study internship.
MD at Szeged University, PhD. in peripheral vascular disease at Semmelweis University, Master in Applied biostatistics at the Veterinary Medicine of Budapest University.
Support department
Camille Desbruères - Business developer and marketing analyst
Various experiences in the pharmaceutical industry and in the research field
End of study internship.
MSc in biopharmaceutical management at ESCP Business School, Master in Microbiology at the Paris-Saclay University
Regulatory and medical affairs
Marius Woitok - Head of Regulatory Affairs
Strong experience in medical writing and revision of regulatory documents for submission to notified bodies of more than 40 medical devices:
Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), and Post Market Clinical Follow-Up (PMCF) Plan/Evaluation report according to MDD and MDR requirements, Risk Management (ISO 14971), Usability Engineering (IEC 62366), Quality Management System (ISO 13485).
B.Sc. Biology, M.Sc. Biomedical Engineering, and Ph.D. In Biomedicine at the RWTH Aachen University.
Zeinab Darwich - Regulatory Affairs Expert
2 years' experience in medical writing and revision of regulatory documents for submission to notified bodies of more than 20 medical devices:
Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), and Post Market Clinical Follow-Up (PMCF) Plan/Evaluation report according to MDD and MDR.
DIU Formation des investigateurs aux essais cliniques des médicaments (FIEC) Paris University and PhD in biophysics and cell biology Strasbourg, France.
Our values
Human-scale
We value the day-to-day well-being of our employees by a personalized management recognizing their unique value by developing their strengths.
Collaborative
"Teamwork is the ability to work together toward a common vision. The ability to direct individual accomplishments toward organizational objectives. It is the fuel that allows common people to attain uncommon results." - Andrew Carnegi
Diversity
We are prioritizing diversity, equity and inclusion
Ethics/Quality
It's the basis of our company's foundation, our DNA.
