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
- Signal detection and causality assessment
- Design and management of safety databases