Expert Pharmaceutical & Device Services

Comprehensive regulatory, safety, and quality solutions for pharmaceuticals and medical devices across Europe.

Trusted by Industry Professionals

"Strong medical writing skills and excellent attention to regulatory detail with deep understanding of both EMA and local requirements. Always delivers high-quality work on time."
Regulatory Affairs Professional
Pharmacovigilance & RA Specialist
"Clear communication skills and solution-oriented approach make him a valuable partner. Works independently and brings a collaborative spirit to every task."
Industry Colleague
Pharmaceutical Professional
"Reliable, professional service with exceptional expertise in regulatory affairs and pharmacovigilance. High level of professionalism and flexibility."
Regulatory Specialist
EU Regulatory Affairs

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
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Medical writing and regulatory 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
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Pharmacovigilance and safety monitoring

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
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EU QPPV services

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
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Regulatory affairs services

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
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Market access and strategy

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
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Quality assurance and pharmaceutical laboratory

Ready to Get Started?

Let's discuss your specific pharmaceutical or device compliance needs and develop a customized solution for your business.

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