Strategic Regulatory Support

Regulatory strategy integrates corporate governance, quality management and product development. From ‘virtual’ start-up to established biotech, we help our clients develop effective strategies aligned with the company’s and product’s lifecycle.

Dynamic Regulatory Environment

While an effective strategy provides a consistent framework to support development, it must also evolve with the highly dynamic regulatory environment in which we operate. We constantly monitor regulatory developments and help our clients foresee and exploit new opportunities.

Unique Development Programs

We recognize that every development program is unique. We approach each project with an open mind and thoroughly explore how all the nuances may impact the development options. Then we identify optimal solutions to meet the needs of our partners, their products and their patients.

  • Regulatory Development Strategies
  • Accelerated Pathways
  • Health Authority Interactions
  • SME Representation at EMA
  • Due Diligence Support for In/Out-Licensing
  • Global Synchronization
  • Quality Management Systems
  • Orphan Disease Designation
  • Pediatric Investigation Plans