Pharmacovigilance services - from system setup to daily operations and EU QPPV. Full-scope or tailored to your needs.
- Modular services tailored to your product lifecycle
- EU & global vigilance expertise
- Independent, transparent and audit-ready processes
Discuss your vigilance needs for MA submission with our experts or contact us at:
Preparing for a Marketing Authorization Application?
FGK offers a regulatory-ready Pharmacovigilance Service Package designed specifically for Marketing Authorization Applications.
We support pharmaceutical, biotech and medical device companies with end-to-end PV services — ensuring all required systems, documentation and processes are aligned, fully compliant and ready for submission.
From SDEA development to PSMF preparation and ICSR processing, we provide a complete PV package for Marketing Authorization Application for your product and beyond.
Pharmacovigilance is critical — and resource-intensive.
Maintaining a compliant vigilance system requires expertise, constant monitoring and significant internal resources. As regulations evolve and product portfolios grow, the workload increases — and the risk of gaps become more serious.
Many companies struggle with:
- Limited internal PV capacity
- Increasing regulatory complexity
- Preparing for inspections and audits
- Scaling vigilance during growth phases
- Ensuring continuity when key staff are unavailable
FGK helps you remove this pressure. We help you design compliant workflows, develop documentation, and implement scalable solutions that support long-term growth.
Our Pharmacovigilance Solutions
We cover:
- Complete Pharmacovigilance (PV) Package for MA Submissions/ Marketing Authorization PV Package (ICSR, PSMF, RMP, EU QPPV, SDEAs & More)
- Build a compliant PV system from scratch
- EU QPPV services by our physicians
- Preparing you for inspections and audits
- Preparing you for market entry or optimizing existing processes
Outsourcing pharmacovigilance allows you to access specialized expertise while reducing internal workload. FGK offers flexible outsourcing models ranging from support for selected activities to full PV system management. Our scalable services enable you to maintain compliance, manage growth and ensure continuity without expanding internal resources.
PV Service Package for Marketing Authorization Applications
Preparing a Marketing Authorization Application requires a fully compliant pharmacovigilance system, complete documentation and clearly defined responsibilities. FGK provides a complete pharmacovigilance package for MA submissions, helping you meet regulatory expectations efficiently while keeping your internal ressources available for other tasks.
Our Marketing Authorization PV Package includes:
Why choose a dedicated PV package for Marketing Authorization?
A structured PV package ensures:
- Faster preparation for submission timelines
- Reduced compliance risks
- Clear documentation for regulators
- Confidence during inspections and audits
FGK acts as your partner throughout the entire Marketing Authorization journey — from preparation to post-approval support.
Why companies choose FGK:
Experienced team
Work experience spanning clinical development through post-marketing phases, strengthened by a very low staff turnover.
Part of FGK Group
Backed by a full-service Clinical Research Organisation, Data Management, Medical Writing, eSolutions and Regulatory group based in Germany.
Modular & scalable approach
Support that grows with your portfolio and organizational needs.
International perspective
Support on national, international and global levels.
Highly professional
We support companies worldwide in maintaining safe and compliant vigilance systems.
Independent & transparent
Clear processes and high-quality standards established during more than 20 years on the market as owner-driven company.
Zurab Koberidze, M.D., Ph.D., MPH
Director Pharmacovigilance, QPPV
Effective communication is vital for successful outsourcing relationships. We prioritize transparency and collaboration on eye-level, ensuring that you remain informed and engaged throughout the process.
Let’s discuss your needs
Whether you need full PV outsourcing, EU QPPV services or additional support for your existing system — FGK is ready to help.
Pharmacovigilance Services - FAQs
Do you provide EU QPPV services?
Yes. We provide experienced EU QPPV and Responsible Person services.
Can we outsource only parts of PV?
Yes. Our services are modular and can support selected activities or full outsourcing.
Do you support small or emerging biotech companies?
Absolutely. Many of our clients scale their PV activities as they grow.
Do you provide dedicated PV database services?
Yes. We can either setup our PV database in house and maintain this or use an existing one.
Can you support us within internal/external audits and inspections?
Yes. As part of pharmacovigilance services, we support our clients within audits and inspections to ensure compliance with Good Pharmacovigilance Practice (GVP).
Do you provide ICSR services?
Yes. We offer the full range of ICSR management and reporting services.
I run a clinical trial. Do you also provide Drug Safety Outsourcing in the course of a running study?
Yes, this can be supported by FGK Group. Just let us know what you need.