Drug/Device Development and Safety

Venebio’s regulatory affairs specialists support our clients in a variety of regulatory submissions and responses to international agencies, while also providing ongoing safety and pharmacovigilance support. Venebio collaborates with biotech and mid-size to large major pharmaceutical companies on design, conduct and data analysis of a wide range of clinical studies. We also design and manage large-scale clinical databases and analyze both proprietary and major public pharmacoepidemiology and pharmacovigilance databases.

Specific areas of expertise include:

  • Regulatory authority meeting preparation, documentation, and participation
  • Regulatory writing
  • Periodic and expedited regulatory reporting
  • Phase I-IV clinical trial design, analysis, and reporting
  • Pharmacovigilance
  • Signal detection and causality assessment
  • Design and management of safety databases