Expert Pharmaceutical & Device Services Across Europe
Comprehensive medical writing, pharmacovigilance, and regulatory affairs solutions for pharmaceuticals and medical devices. Ensuring compliance, safety, and market success.
Our Core Services
Specialized expertise in pharmaceutical and medical device regulatory affairs, safety, and quality assurance
Medical Writing
Expert medical writing for clinical, regulatory, and post-marketing documentation across pharmaceuticals and medical devices.
Learn more →Pharmacovigilance
Comprehensive drug and device safety monitoring, adverse event management, and vigilance activities ensuring patient safety.
Learn more →EU QPPV/LSO Services
Qualified Person for Pharmacovigilance and Local Safety Officer services ensuring continuous oversight throughout Europe.
Learn more →Regulatory Affairs
Expert guidance through complex regulatory processes for pharmaceuticals and medical devices across European markets.
Learn more →Market Access
Strategic market access planning and health economics support for successful product launch and reimbursement.
Learn more →Quality Assurance
Rigorous quality control systems and validation processes maintaining the highest standards for pharmaceutical and device manufacturing.
Learn more →Why Choose Noetus Solutions
Combining medical expertise with regulatory knowledge to deliver exceptional pharmaceutical and device compliance services
Expert Knowledge
Advanced certifications from Johns Hopkins, UC San Diego, and NIH. Deep understanding of EU pharmaceutical and device regulations.
Rapid Response
Fast turnaround times for critical regulatory submissions, safety reporting, and medical writing projects.
Compliance Assured
Guaranteed compliance with EMA, FDA, and local regulatory requirements. Up-to-date with latest guidelines.
Trusted Partner
Peer-recommended by industry professionals. Reliable, professional service with a collaborative approach.
European Coverage
Comprehensive knowledge of EU regulatory frameworks across all member states. Experience with EMA, national authorities, and local requirements.
Comprehensive Services
Full-spectrum support from medical writing and clinical trials to post-market surveillance and regulatory lifecycle management.
What Clients Say
Trusted by industry leaders across pharmaceuticals, biotechnology, and medical devices
Consistently delivered high-quality work on time. Dependable, proactive, and often went above and beyond.
High-quality Clinical Evaluation Reports—compliant, professional, patient-centered and scientifically rigorous.
Demonstrated critical thinking in medical evaluation. Motivated and flexible—helped achieve very tight timelines.
Strong command of global PV regulations, excellent clinical insight, and clear, structured communication style.
Very dedicated, smart and easily resolves all tasks. Highly adaptable to new and unexpected situations.
His scientific rigor and collaborative spirit made him a valuable asset to the team.
Broadened knowledge in Medicine, Clinical Trials and Pharmacovigilance combined with humble, caring, and natural leader traits.
Approaches work with humility, precision, and strong communication—qualities that make him stand out in the field.
Caring, devoting and compassionate personality. Astute minded and analytically oriented.
His approach is always patient-centered and forward-thinking. A true asset to any safety or medical writing team.
Very smart and integrated quickly into the team. I would like to work with David again!
Intuitive about our needs and gave us full description of best practice for our project.
Always willing to go far and beyond. Someone you would always like to have in your team.
Professional in the industry with pleasurable communication skills, responsive and attentive to deadlines.
Demonstrated unique interpersonal skills and highly experienced professional knowledge in pharmacovigilance.
Great connections in Hungary and all over Europe. Expert in clinical trials—very easy to work with.
Excellent support for our efforts. Despite the distance, we had excellent daily communication.
Trusted by Global Life-Science Leaders
Noetus Solutions has provided expert support in pharmacovigilance, regulatory affairs, medical writing, clinical operations, and quality systems to leading pharmaceutical, biotechnology, and medical-device organizations across Europe and the US.
Logos are for illustrative purposes only and represent organizations to which Dr. Marmaros has provided professional services. All trademarks and brand marks are the property of their respective owners. No endorsement is implied.
Latest Regulatory Insights
Expert guidance on pharmaceutical and medical device compliance
Medical Device Safety: MDR/IVDR Compliance
Essential guide to device safety requirements and post-market surveillance
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Safety Information Management in Pharmacovigilance
Best practices for safety data management and signal detection
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Post-Market Surveillance Best Practices
Comprehensive PMS strategies for pharma and medical devices
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Understanding the Common Technical Document
Complete guide to CTD structure and regulatory submissions
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Writing Clinical Study Reports: ICH E3
ICH E3 guidelines for comprehensive clinical study documentation
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CTD vs MDR: Key Differences Explained
Understanding pharmaceutical vs device regulatory pathways
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ISO 14971: Risk Management for Devices
Practical guide to implementing device risk management
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ICH E6(R2): Good Clinical Practice Updates
Key changes in GCP guidelines and risk-based approaches
Read More →
Preparing the IMPD for Clinical Trials
Step-by-step guidance on IMPD compilation and submission
Read More →Ready to Ensure Compliance?
Let's discuss how our expertise can support your pharmaceutical or medical device projects and ensure regulatory success across Europe and the US.