Pharmacovigilance & drug-safety counsel.
Marketing-authorisation holders must operate a pharmacovigilance system to monitor and report the safety of their medicines. The firm provides the legal layer: safety-reporting obligations under Swiss HMG/AMBV and EU GVP, QPPV and safety-data-exchange agreements (SDEA), signal-management and CAPA legal review, and audit and inspection readiness.
Who this is for
- Marketing-authorisation holders and affiliates operating Swiss or EU PV systems.
- Companies outsourcing the QPPV interface or safety-data exchange.
- Sponsors structuring safety-data exchange with development or distribution partners.
What's included
Legal support for the pharmacovigilance system under HMG and AMBV and EU GVP: safety-reporting obligations, QPPV and safety-data-exchange agreements (SDEA), signal-management and CAPA legal review, and audit and inspection readiness.
How it works
- System review. The firm reviews the client's pharmacovigilance system against the applicable Swiss and EU duties.
- Agreements. The firm drafts or reviews QPPV and safety-data-exchange agreements (SDEA).
- Reporting. The firm advises on safety-reporting obligations and timelines.
- Signal & CAPA. The firm provides legal review of signal-management and corrective-action processes.
- Inspection readiness. The firm prepares the client for audits and authority inspections.
Indicative pricing
Subscription + fixed-fee modules
from CHF 5,500 / month
Modules CHF 5,000 to 18,000; per-country local-contact-person coverage from CHF 700 / month.
Indicative starting prices, net and exclusive of Swiss MWST (VAT) where applicable; final fee per written engagement letter.
Frequently asked questions
- What is a QPPV and is one required?
- A Qualified Person Responsible for Pharmacovigilance (QPPV) is the individual accountable for a marketing-authorisation holder's pharmacovigilance system in the EU; Swiss law has a corresponding responsible-person concept (Art. 12 AMBV). The firm advises on the role and drafts the contractual arrangements where it is outsourced; the specific statutory duties are confirmed at engagement.
- What is a safety-data-exchange agreement (SDEA)?
- When two or more companies share responsibility for a product (for example a licensor and licensee, or co-marketing partners), an SDEA allocates who collects, assesses and reports safety data, and on what timelines. The firm drafts and negotiates these agreements so the obligations are unambiguous.
- How do Swiss and EU pharmacovigilance duties relate?
- A company active in both markets runs one pharmacovigilance system that must satisfy Swiss therapeutic-products law and EU good pharmacovigilance practices in parallel. The firm aligns the legal obligations across both rather than treating them separately.