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Efficient and Effective

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Arciel provides regulatory consulting 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)
• Medical / Scientific / Protocol / CSR Writing

Other related services are available through Arciel Colleagues.

• US FDA Regulatory Submissions through Pointerro, LLC .
  • Document lifecycle management
  • Regulatory writing
  • Publishing (paper and electronic)
  • ESG setup and E-transmissions

• CMC, Nonclinical, and Clinical development expertise available through Arciel Colleagues.

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