Local Contact Person (LCP) & Pharmacovigilance Services in Germany

My Services

Official Representation in Germany as Your LCP

Appointed Local Contact Person (LCP) for Germany

I act as your official LCP and point of contact for the BfArM and PEI, ensuring full compliance with national pharmacovigilance laws and guidelines.

Local Literature Screening

Conducting systematic screening of national literature for adverse drug reactions (ADRs), safety studies, and relevant pharmacovigilance data including relevant journals and sources recognised by BfArM and PEI.

PRAC Screening

Monitoring the Pharmacovigilance Risk Assessment Committee (PRAC) recommendations, regulatory updates, and safety signals to ensure timely compliance with evolving regulations.

Handling Local Regulatory Inquiries

Management of inquiries from BfArM and PEI, including preparation of responses, translations, and coordination with the EU-QPPV or global PV team.

Medical Inquiries & Expert Responses

As a licensed pharmacist, I provide scientifically sound responses to healthcare professionals and patients.

Supporting National PV Requirements

Assisting in the preparation and maintenance of local pharmacovigilance documentation, including risk management plans and periodic safety reports

Local ICSR Management

Support with collection and follow-up of local ICSRs in accordance with regulatory expectations.

Audit & Inspection Readiness (BfArM & PEI)

Support during national PV inspections or audits to ensure you are always inspection-ready and fully compliant.

Implementation of Additional Risk Minimisation Measures (aRMMs) and DHPCs

Supporting the local adaptation and dissemination of educational materials and Direct Healthcare Professional Communications (DHPCs) to ensure patient safety.

Regulatory Intelligence

Proactive updates on German pharmacovigilance legislation and implementation support for your processes and documentation.

I support you in fulfilling your national pharmacovigilance obligations with efficiency and regulatory confidence. My services include:

✔ GVP & AMG Compliance

Fulfil all national pharmacovigilance obligations and avoid non-compliance risks in Germany.

✔ Efficient Communication with Authorities

Maintain a seamless connection with national health authorities, ensuring timely responses to inquiries and updates.

✔ Integrated Local & Global PV

Seamless integration of national activities into your EU or global PV system – no duplication, no gaps.

✔ Cost-Effective Outsourcing

Gain access to local PV support without the need to build your own in-house structure.

✔ Inspection-Proven Support

Benefit from my hands-on experience with BfArM and PEI inspections, helping you stay prepared and confident at all times.

Your Benefits

Local Expertise. Global Compliance.

Need a Local Contact Person (LCP) in Germany?

Let’s ensure your local pharmacovigilance responsibilities are covered - compliantly, and efficiently.

Get in touch to find out how I can support your national PV setup and ensure smooth collaboration with German authorities.