Expanding into non-EU markets opens major growth opportunities for pharmaceutical companies – but it also introduces complex regulatory challenges, particularly in pharmacovigilance (PV).
While EU Good Pharmacovigilance Practices (EU GVP) primarily govern products authorised within the EU, global PV responsibilities often extend beyond Europe. Safety data from non-EU territories can impact EU benefit-risk assessments and regulatory reporting obligations.
A structured, compliant PV framework is therefore essential – not only to meet EU expectations but also to secure local approvals, build reliable partnerships, and ensure sustainable market success.
With my expertise, you gain tailored support to ensure your pharmacovigilance system is globally aligned, locally compliant, and ready for international expansion.
International Expansion & Pharmacovigilance Compliance
Support for EU Companies Entering Non-EU Markets – and Non-EU Companies Collaborating with Europe
Why Is PV Compliance Critical When Expanding Internationally?
PV Consulting for Non-EU Expansion
Strategic advice on regulatory challenges and pharmacovigilance requirements in new target markets – aligned with your EU GVP obligations.
Drafting & Negotiating PV Agreements (PVAs)
Support in creating and negotiating PV agreements that ensure clear role definitions and compliance with global pharmacovigilance standards.
PSSF/PSMF Setup & Maintenance
Creation and maintenance of global or local Pharmacovigilance System Master Files (PSMFs) and Pharmacovigilance Sub System Files (PSSFs) for international operations.
My Services – Supporting EU Companies Expanding Into Non-EU Markets
Pharmacovigilance Training for Non-EU Partners
Tailored training sessions for distributors, license partners, and local representatives to ensure understanding and fulfilment of PV responsibilities.
Pre-Qualification & Auditing of Non-EU Partners
Assessment and auditing of new partners to verify compliance readiness before engagement – mitigating risks early.
Partner Management & Ongoing Oversight
Structured management of international PV partners to ensure transparency, regulatory compliance, and smooth collaboration over time.
Non-EU companies planning to collaborate with European pharmaceutical companies must meet strict EU-GVP requirements – even if the product is initially registered outside the EU.
I help non-EU companies to:
Understand EU-GVP Requirements
Guidance on the pharmacovigilance standards and QMS requirements expected by EU partners and authorities.
Set Up a PV Quality System
Establishment of GVP-compliant pharmacovigilance processes and a documented quality framework.
Prepare for Partnership Readiness
Support in aligning internal processes and documentation, to ensure seamless qualification and onboarding by EU companies.
Without structured PV processes, partnerships with EU companies are often delayed or fail altogether – I help you avoid those risks and ensure regulatory and operational readiness.
My Services – Supporting Non-EU Companies Entering the European Market
Global PV Alignment
Ensure that your pharmacovigilance system meets both EU and local regulatory requirements.
Faster Market Access
Accelerate regulatory approvals and partner onboarding by avoiding compliance gaps.
Reduced Partnership Risks
Demonstrate qualification readiness to EU partners – avoiding delays, rework, and lost opportunities.
Sustainable Growth in New Markets
Build scalable, compliant PV systems that support your long-term international success.
Inspection-Ready Documentation
Ensure that your pharmacovigilance documentation withstands audits and inspections in all relevant territories.
Your Benefits – Confident, Compliant International Expansion
Planning to expand your pharmacovigilance system internationally?
Whether you are an EU company growing into new markets or a non-EU company entering Europe – I support you with strategic advice, operational setup, and regulatory alignment.
Contact me for a tailored consultation.
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