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.
Latest Regulatory Insights
Expert guidance on pharmaceutical and medical device regulatory processes
Understanding the Common Technical Document
A comprehensive guide to CTD structure and regulatory submission requirements.
Read article →
Clinical Study Reports: ICH E3 Guidelines
Learn the structure and content requirements for Clinical Study Reports.
Coming soon →
CTD vs MDR: Documentation Compared
Understanding differences between pharmaceutical and device documentation.
Coming soon →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.
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.