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

Our regulatory specialists have years of experience in submissions to and meetings with the following agencies:

  • FDA
  • EMA (Europe)
  • Individual EU drug regulatory authorities
  • Health Canada
  • MHLW (Japan)
  • CFDA (China)
  • DCA (Malaysia)
  • MoH (Argentina, Brazil, Israel)
  • MCC (South Africa)
  • TGA (Australia)

Regulatory submissions our experts have supported:

  • NDAs
  • sNDAs
  • Type C Briefing Packages
  • Breakthrough Therapy Designation
  • Orphan Drug Applications
  • Type II Variations (EMA)

Representative Projects Include:

Authored a Request for Breakthrough Therapy Designation to the FDA, resulting in the first ever acceptance of a CNS compound.

Established and led a global safety signal-detection program for a mid-sized pharmaceutical company.

Delivered a successful response to a regulatory pharmacovigilance request that prevented restraint of a global product’s marketing authorization.

Evaluated effectiveness of innovative pharmaceutical packaging in reducing pediatric exposure.

Created and directed a global signal detection program, including submission to the FDA and EMA of an sNDA for safety-related label change.

What Our Clients Say:

Our organization has benefited across the pipeline from Venebio’s unique and visionary business model. Numerous times in years past, we have asked Venebio to leverage its growing global network of experts. With every new engagement, Venebio moves swiftly to put together a project-specific team, built around some of the world’s leading talent, whether in clinical trial design and analysis, personalized medicine, pharmacovigiliance, pharmacoepidemiology or patent due diligence support, to provide consistently high-quality, on-time deliverables to our business.

Christian Heidbreder, PhD, Global Head of R&D, Indivior, Inc.