Comprehensive Pharmaceutical Services
From drug safety monitoring to regulatory submissions, we provide end-to-end pharmaceutical compliance solutions across Europe.
Our Core Services
Pharmacovigilance
Comprehensive drug safety monitoring and adverse event management to ensure patient safety and regulatory compliance across all European markets.
- Adverse Event Reporting (AER)
- Periodic Safety Update Reports (PSUR)
- Risk Management Plans (RMP)
- Signal Detection & Management
- Safety Database Management
- Regulatory Authority Liaison
Regulatory Affairs
Expert guidance through complex regulatory processes, ensuring successful market authorization and compliance across European jurisdictions.
- Marketing Authorization Applications (MAA)
- Regulatory Strategy Development
- Dossier Preparation & Submission
- Regulatory Intelligence
- Post-Market Surveillance
- Regulatory Authority Meetings
Quality Assurance
Rigorous quality control systems and validation processes to maintain the highest standards of pharmaceutical manufacturing and distribution.
- GMP Compliance Auditing
- Quality System Implementation
- Validation & Qualification
- Deviation Management
- CAPA Systems
- Supplier Qualification
EU QPPV Services
Qualified Person for Pharmacovigilance services ensuring continuous oversight of drug safety throughout the European Union.
- QPPV Designation & Representation
- Pharmacovigilance System Master File (PSMF)
- Safety Data Review & Assessment
- Regulatory Liaison & Communication
- Audit Preparation & Support
- Training & Competency Development
Interim MA Holder
Temporary marketing authorization holder services for seamless business transitions and regulatory continuity during corporate changes.
- Temporary MA Holder Services
- Regulatory Transition Management
- Business Continuity Planning
- Compliance Maintenance
- Stakeholder Communication
- Handover Documentation
Consulting Services
Strategic consulting on pharmaceutical development, regulatory strategy, and compliance optimization for successful market entry.
- Regulatory Strategy Development
- Compliance Gap Analysis
- Market Access Planning
- Due Diligence Support
- Training & Capacity Building
- Process Optimization
Our Process
Initial Assessment
We analyze your current situation and regulatory requirements to develop a tailored compliance strategy.
Strategic Planning
Our experts create a comprehensive plan with timelines, deliverables, and regulatory milestones.
Implementation
We execute the plan with regular monitoring, quality checks, and progress reporting throughout the process.
Ongoing Support
Continuous monitoring and support to ensure long-term compliance and successful market presence.
Ready to Get Started?
Let's discuss your specific pharmaceutical compliance needs and develop a customized solution for your business.