Regulatory Assistance for Startups

Reguliance specializes in working with pharmaceutical startups and early development companies that typically have limited or no in-house regulatory support.  We address the special needs of these firms by becoming your “external employee” and an integral team player.  Limited resources are used wisely, projects remain manageable, and the oversight burden is reduced, allowing small groups to move nimbly through development.

We can address your global needs through alliance partners, regional service providers with hands-on practical expertise in foreign markets, while retaining an integrated approach to development and strategy.  Alliance partners eliminate the inherent overhead costs and management difficulties associated with larger global consulting firms that staff and manage several offices in various countries.

Reguliance can help address the following questions for your specific development project:

  • Is there any benefit to filing FDA submissions or meeting with the FDA?
  • What are the activities and timelines for FDA submissions and meetings with the FDA and how does this integrate with our other development activities?
  • How should we integrate FDA regulatory activities with EMA or Health Canada?
  • What is the value proposition for our investors and potential investors in having US regulatory activity?