Regulatory Affairs Support for Success

Efficient and Effective

Arciel provides regulatory consulting and operations services to its clients for development of investigational new drugs, biologics, biotechnology products (e.g. drug delivery technology), and combination products.

US FDA Regulatory Consulting

  • Submissions management and strategy
  • FDA communications including Formal Meetings
  • Sponsor’s liaison to FDA (including acting as US IND Agent)
  • Sponsor’s Regulatory Functional Area Head

US FDA Regulatory Submissions (i.e. pre-INDs, INDs, Orphan Drug Designations, and more)

  • Document lifecycle management
  • Regulatory writing
  • Publishing (paper and electronic)
  • ESG setup and E-transmissions

CMC, Nonclinical, and Clinical development expertise available through Arciel colleagues.

Medical Device regulatory expertise available through Arciel colleagues.

Regulatory consulting for EU EMA and other non-US countries available through Arciel colleagues.