Daniel W. Frank

Regulatory Affairs Consultant


Mr. Frank has strong knowledge of regulatory and compliance for all phases of drug development, investigational and marketing applications, post-approval changes and GMP. He brings a manufacturing and compliance perspective to his writing with his career spanning from API to finished product manufacturing.

He provides expertise in all aspects of CMC including API requirements, formulation development, scale-up, manufacturing, submission/change requirements and validation for oral, topical, and injectable dosage forms.

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Core Competencies

  • Life Cycle Management
  • Author IND/NDA
  • Technical Writing
  • eCTD Formatting
  • Briefing Books
  • Program Management
  • IQ/OQ/PQ Review
  • Supplier Agreements