Expert Pharmaceutical & Device Services
Comprehensive regulatory, safety, and quality solutions for pharmaceuticals and medical devices across Europe.
Our Core Services
Medical Writing for Pharmaceuticals & Devices
Expert medical writing services for clinical, regulatory, and post-marketing documentation across pharmaceuticals and medical devices, ensuring scientific accuracy and regulatory compliance.
- Clinical Study Reports (CSRs) & Protocols
- CTD Modules (2.5, 2.7) & IMPD Documentation
- Post-Marketing Documents (PSURs, RMPs, DSURs)
- Literature Reviews & Meta-Analyses
- Investigator Brochures & Patient Information
- Scientific Publications & Manuscripts
- Medical Device Technical Documentation
Pharmacovigilance for Pharmaceuticals & Devices
Comprehensive drug and device safety monitoring, adverse event management, and vigilance activities ensuring patient safety and regulatory compliance.
- Adverse Event Reporting (AER) & Case Processing
- Periodic Safety Update Reports (PSUR/PBRER)
- Risk Management Plans (RMP) & Safety Specifications
- Signal Detection & Management
- Medical Device Vigilance (MDR/IVDR)
- Safety Database Management
- Regulatory Authority Liaison
EU QPPV & Local Safety Officer Services
Qualified Person for Pharmacovigilance and Local Safety Officer services ensuring continuous oversight of drug and device safety throughout Europe.
- QPPV Designation & Representation
- Pharmacovigilance System Master File (PSMF)
- Local Safety Officer (LSO) Services
- Safety Data Review & Assessment
- Regulatory Liaison & Communication
- Audit Preparation & Support
- Training & Competency Development
Regulatory Affairs for Pharmaceuticals & Devices
Expert guidance through complex regulatory processes for both pharmaceuticals and medical devices, ensuring successful market authorization across Europe.
- Marketing Authorization Applications (MAA)
- Medical Device Regulatory Strategy (MDR/IVDR)
- Dossier Preparation & CTD Compilation
- Variations & Post-Authorization Changes
- Regulatory Intelligence & Strategy
- CE Marking & Notified Body Liaison
- Regulatory Authority Meetings
Market Access & Reimbursement
Strategic market access planning and health economics support to ensure successful product launch and reimbursement across European markets.
- Market Access Strategy Development
- Health Technology Assessment (HTA) Support
- Pricing & Reimbursement Dossiers
- Health Economics & Outcomes Research (HEOR)
- Payer Engagement & Negotiation Support
- Value Proposition Development
- Market Entry Planning
Quality Assurance
Rigorous quality control systems and validation processes maintaining the highest standards for pharmaceutical and device manufacturing.
- GMP/GDP Compliance Auditing
- Quality System Implementation (ISO 13485)
- Validation & Qualification
- Deviation & CAPA Management
- Supplier Qualification & Audits
- Risk Management (ISO 14971)
- Quality Documentation & SOPs
What Clients Say
Trusted by industry leaders across pharmaceuticals, biotechnology, and medical devices
Ability to interpret complex safety data and align stakeholders across functions was instrumental to our work.
Fast learner, ready to contribute to the team in no time. Plays as team player but not lacking individual approach.
Strong ownership of key deliverables such as PMCF plans and reports. Dependable and proactive.
Able to use technology and medical knowledge together with empathic listening skills to arrive into accurate diagnoses.
Ability to adapt to different device types and regulatory requirements made him a trusted and reliable partner.
It was pleasure sharing thoughts on different PV topics. I would like to work with David again!
Highest quality services and full dedication to their project in the life-sciences fields.
Collaborative, dependable, and intellectually curious—a true asset to any safety team.
We would not have been able to do this in the time available without David. Looking for the next collaboration.
I look forward to continuing our work together and would highly recommend him in any future collaboration.
Contributed knowledge with data analyses, scientific and strategic assessments. Highly recommend and will for sure hire again!
I am honoured I had a chance to meet him and work with him.
Allowed the successful build of our team and gain high trust from our client.
Very easy to explain what exactly are my needs and to get best quotes from appropriate service providers.
Excellent support for our efforts to identify clinical sites in Europe. Excellent daily communication.
Ready to Get Started?
Let's discuss your specific pharmaceutical or device compliance needs and develop a customized solution for your business.