Comprehensive Life Sciences Services
End-to-end support from concept to product with specialized regulatory, clinical, and business expertise across Europe
Our Comprehensive Services
Expert solutions across the entire pharmaceutical and medical device lifecycle
Clinical Trial Services
Comprehensive clinical research management from protocol to submission
- Protocol design and development
- Site identification and management
- Patient recruitment and retention
- Clinical data management and monitoring
- Biostatistics and data analysis
- Regulatory submissions and approvals
Pharmacovigilance & Safety
Comprehensive safety monitoring for drugs and medical devices throughout product lifecycle
- Adverse event case processing and reporting (drugs & devices)
- Signal detection and risk management
- EU QPPV and PRRC (Person Responsible for Regulatory Compliance)
- Periodic safety reports (PSUR/PBRER/DSUR/PSUR for devices)
- Risk Management Plans (RMP) and device vigilance
- Safety database management and EUDAMED reporting
Regulatory Affairs & CMC
Strategic regulatory guidance from development to market
- Marketing Authorization Applications (MAA)
- Clinical Trial Applications (CTA)
- Variation submissions and lifecycle management
- CMC documentation and strategy
- Regulatory intelligence and gap analysis
- Health authority interactions
Quality & Compliance
Ensuring GxP compliance across all operations
- Quality system implementation
- GMP/GCP/GLP compliance
- Audit preparation and support
- SOP development and training
Market Access & Reimbursement
Strategic market access solutions for successful product launches across Europe
- Health Technology Assessment (HTA) strategy and submissions
- Pricing and reimbursement negotiations
- Health economics and outcomes research (HEOR)
- Payer engagement and value dossier development
- Real-world evidence generation and analysis
- Market access landscape assessment
Medical Device Regulatory Services
Complete regulatory support for medical devices under EU MDR and IVDR
- MDR/IVDR compliance and CE marking
- Technical documentation and clinical evaluation
- ISO 13485, ISO 14971, ISO 14155 implementation
- Notified Body liaison and submissions
- Post-market surveillance and vigilance
- PMCF and PMPF study design
Medical Writing
Scientific documentation for regulatory success
- Clinical study reports
- Regulatory dossiers
- Scientific publications
- Patient information leaflets
EU Distribution & Logistics
Complete pharmaceutical and medical device distribution solutions across Europe
- GDP-compliant distribution network setup
- Wholesale distribution authorization (WDA)
- Cold chain and temperature-controlled logistics
- Import/export licensing and customs clearance
- Parallel trade and cross-border distribution
- Serialization and track-and-trace compliance
Business & Commercial Services
Complete business support for pharma & device success
- Business development & licensing
- Asset valuation & portfolio optimization
- Commercial strategy & launch excellence
- Financial advisory & fundraising
Regulatory Intelligence
Stay ahead of regulatory changes with comprehensive monitoring and analysis services
- Real-time monitoring of NNGYK/OGYÉI updates
- NEAK reimbursement policy tracking
- Regulatory impact assessments
- Translated summaries in English
- Competitive intelligence and landscape analysis
- Regulatory horizon scanning
QPPV Intelligence Hub
Real-time Hungarian pharmaceutical intelligence and regulatory updates from our dedicated platform
- Daily updates on drug withdrawals and recalls in Hungary
- OGYÉI (Hungarian National Institute of Pharmacy) regulatory news
- NEAK market access and reimbursement changes
- Hungarian pharmaceutical market intelligence
- Translated regulatory updates (Hungarian → English)
- Subscription-based intelligence service
Due Diligence
Comprehensive regulatory assessments for informed business decisions
- Regulatory status reviews
- Portfolio assessments
- Risk analysis and mitigation strategies
- Market entry feasibility studies
Training & Education
Build your team's expertise in regulatory affairs and compliance
- Hungarian regulatory landscape training
- PV requirements and best practices
- Market access strategies
- Customized workshops and seminars
Labeling & Notification Services
Complete regulatory support for food supplements, cosmetics, and medical devices in Hungary
- Translation of labels (ENG → HU)
- Ingredient assessment & compliance review
- Product notification and registration
- Medical devices (Class I, IIa, IIb)
- Food supplements & cosmetics
- Distributor registration
What Clients Say
Trusted by industry leaders across pharmaceuticals, biotechnology, and medical devices
Consistently delivered high-quality work on time. Dependable and proactive.
Demonstrated critical thinking in medical evaluation. Motivated and flexible.
High-quality Clinical Evaluation Reports—compliant, professional, and patient-centered.
Very dedicated and smart. Easily resolves all tasks with precision.
Strong command of global PV regulations and excellent clinical insight.
Often went above and beyond. His scientific rigor made him a valuable asset to the team.
Broadened knowledge in Medicine, Clinical Trials and Pharmacovigilance.
Scientifically rigorous work. Approaches everything with humility, precision, and strong communication.
Professional with excellent communication skills. Responsive and attentive to deadlines.
Helped achieve very tight timelines with excellent attention to detail.
Humble, caring personality combined with natural leadership traits.
Clear, structured communication style that makes complex topics accessible.
Highly recommend! Always delivers quality work on schedule.
Highly adaptable to new and unexpected situations. A true problem solver.
Demonstrated unique interpersonal skills in pharmacovigilance.
Highly experienced professional knowledge and excellent collaboration.
Caring and compassionate personality. Astute minded and analytically oriented.
I wholeheartedly recommend David for any medical or regulatory project!
Intuitive about our needs. Provided full description of best practices.
Great connections in Hungary and all over Europe. Expert in clinical trials.
Very easy to work with. Professional and knowledgeable.
Excellent support for our efforts. Outstanding daily communication.
Despite the distance, communication was seamless and effective.
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.
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