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.

Initial set-up

• 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.