Safety Agreements (SDEA)
Licensing of pharmaceutical products and outsourcing means that a clear and well-defined concept for exchange of pharmagovigilance data is in place.
We prepare PV agreements and safety data exchange agreements taken into account your and your business partners capabilities.
As basis we offer due diligence audits to analyse PV strength and weaknesses. Due Diligence means to evaluate what risk is involved in doing business with an entity prior to establishing a relationship and assessment of risk at that point in time. This holds true also for Pharmacovigilance partner.
We support you in negotiations and adjustments.
Follow-up and maintenance
- Furthermore we follow-up and update your contractual arrangements.
- If new circumstances and/or regulations make an update necessary we inform you in due course and implement the changes in close cooperation with you.
- We professionally manage your contracts including first drafts, follow-up and updates of your contractual arrangements - as necessary.
Contact us. We are looking forward to your enquiry.