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Efficient and Effective

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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)

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.

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