The regulatory landscape surrounding drug and device development is complex, but having the right partner with regulatory and pharmaceutical experience can make that navigation significantly easier.

Understanding the global drug and device industry

Getting your drug or device to market means complying with rapidly evolving domestic and international regulatory requirements. Our expertise and industry experience helps clients anticipate and respond to whatever regulatory requests or requirements await them.

Our consultants can help lighten the load by providing analytics, coding, agency-facing reports, and strategic regulatory support and engagement as your organization moves through this process.

Some of Venebio’s drug and device development and safety capabilities include:

Clinical Trials

  • Design and analysis
  • Narrative or systematic reviews of safety and efficacy
  • R&D strategy

Regulatory Affairs

  • Report writing and submission
  • Agency meeting preparation (Type C and AdComm), attendance and response


  • Post-marketing signal detection
  • Review of safety communications and patient narratives
  • Design, conduct, and publication of safety-related database studies
  • Safety database analyses including but not limited to: Argus, FAERs, WHO, MHRA and MAUDE

We are experienced with a variety of regulatory submissions:

NDAs and sNDAs
Type C Briefing Packages
AdComm packages
Breakthrough Therapy Designation
Orphan Drug applications
Type II Variations
Integrated Summary of Safety
Risk management programs including REMS

We meet and interact with the following regulatory agencies:

EMA and individual EU regulatory authorities
Health Canada