• Product Development
    and Commercialization

Streamlining product development and ensuring regulatory compliance.

Along with high regulation, the life sciences industry is facing a multitude of challenges. Recent trends toward developing products for rare and orphan disease products carry associated difficulties with patient recruitment, market competition, and patent expiration pressures – all which contribute to higher costs of development. While FDA approvals have been on the rise, the road to market is long and fraught with risk.
 
At BDO, we help innovative companies become even more innovative. Our team of industry veterans with an average of 20+ years of experience offers a wide variety of support and services, helping our clients in all stages of the product development lifecycle, including:
 
Technical and Operations Support
  • Clinical operations
  • Regulatory
  • Chemistry, manufacturing & controls
  • Quality systems
  • Technology transfers 
Commercial Strategy Market Assessments and Differentiation
  • Competitive analysis (emerging and marketed)
  • Commercial product profiles
  • Product valuations
  • Price benchmarking and recommendations
  • Licensing and business development
  • Reimbursement for U.S. and EU 
Risk Management and Risk Remediation
  • Risk assessment and risk management
  • cGXP compliance assessments
  • PAI readiness assessments
  • cGXP audits
  • Resolution of FDA 483s
  • “For Cause” audits and FDA consent decrees
  • Project management and execution of corrective action plans