About Dr. David Marmaros, MD
Medical doctor with cross-industry expertise in pharmaceuticals and medical devices, specializing in medical writing, regulatory affairs, and pharmacovigilance across clinical and post-marketing phases throughout Europe and the US.
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Professional Background
Dr. David Marmaros, MD is a medical doctor with advanced certifications from world-renowned institutions including Johns Hopkins Bloomberg School of Public Health, University of California San Diego, and the NIH Clinical Research Program. His expertise bridges both pharmaceuticals and medical devices, with particular strength in medical writing (CSRs, CTD modules, PSURs, RMPs, technical documentation), regulatory affairs (MAAs, variations, MDR/IVDR compliance), and pharmacovigilance across clinical trials and post-marketing surveillance.
🌍 Cross-Industry Expertise: Pharmaceuticals & Medical Devices
Dr. Marmaros, MD serves leading pharmaceutical companies, biotech firms, and medical device manufacturers across Europe and the US. His dual expertise in pharma and devices enables seamless support from clinical development through post-marketing phases. He excels in medical writing (Clinical Study Reports, CTD Modules 2.5/2.7, PSURs, RMPs, Investigator Brochures, device technical documentation), regulatory affairs (MAAs, MDR/IVDR compliance, CE marking, variations), and pharmacovigilance (AER, signal detection, QPPV services). His proven track record of successful submissions and comprehensive safety programs delivers reliable, professional services meeting the highest industry standards.
His comprehensive knowledge encompasses medical writing for both pharmaceuticals and devices (clinical and post-marketing documents), EU marketing authorization procedures (MRP, DCP, CP), MDR/IVDR regulatory pathways, clinical trial design and management, and biostatistics. With specialized training in pharmacovigilance audits and inspections from the Drug Information Association (DIA), Dr. Marmaros provides cutting-edge solutions for complex pharmaceutical and device challenges across the entire product lifecycle—from clinical development through post-market surveillance.
Dr. Marmaros's medical training, combined with his cross-industry experience in pharma and devices, solution-oriented approach, and collaborative spirit, ensures exceptional service delivery. Whether drafting Clinical Study Reports, preparing CTD dossiers, managing device technical documentation, conducting regulatory submissions, or overseeing pharmacovigilance activities, his commitment to scientific excellence and regulatory integrity has earned him recognition as a trusted partner across both pharmaceutical and medical device industries.
Professional Certifications & Training
Advanced qualifications from prestigious institutions worldwide
Advanced Clinical Research Project Manager
Comprehensive certification in clinical trial design, management, ethics, and regulatory compliance. Demonstrates expertise in managing complex clinical research projects.
Design and Conduct of Clinical Trials
Specialization covering clinical trials operations, data management, quality assurance, and statistical analysis from one of the world's leading public health institutions.
Principles of Clinical Research
Comprehensive training in clinical pharmacology, research ethics, and regulatory aspects of clinical research from the National Institutes of Health.
Drug Development Specialization
Complete drug development lifecycle training covering drug discovery, development, product management, and commercialization strategies.
Advanced Pharmacovigilance Audits & Inspections
Specialized training in pharmacovigilance system audits and regulatory inspections, accredited by SwAPP and SGPM.
EU Marketing Authorisation
Comprehensive training in EU regulatory network, MRP, DCP, and CP procedures for marketing authorization applications across European markets.
EU Variation System & Procedures
Six-module certification covering variation classification, post-authorization changes, and lifecycle management of medicinal products.
Biostatistics Rx
Advanced statistical analysis and biostatistics training for clinical research and regulatory submissions.
Client Testimonials
Trusted by pharmaceutical professionals across Europe and the US
Ready to Work Together?
Let's discuss how my expertise can support your pharmaceutical or medical device projects and ensure regulatory success across Europe and the US.