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.

Audits

Pharmaceutical companies are regulatory obliged to ensure internal and compliance of contracted partner through audits >>

Processes - SOPs

PV processes should comply with regulatory requirements (such as GVP Modules) through corresponding conception, design and implementation >> >>