Strategy Extraordinaire

DMPK, Industry Practice, FDA, Pharm/Tox and Everything Else We Know

The senior consultants and consultants at Aclairo have extensive experience evaluating and advising on FDA, DMPK, and pharmacology/toxicology issues encompassing virtually all classes of drugs and biologics. We focus on facilitating the successful design of and strategy for your development program.

Aclairo Services include:

  • Applying our industry and FDA experience and 20+ years for each senior consultant to your problem or plan
  • Understanding your goals, and helping you reach them
  • Realistic strategies, with back up plans
  • FDA and international toxicology strategies
  • Regulatory submission planning, review, and interpretation
  • Critical scientific thinking and planning
  • Excipient expert review
  • Study design and interpretation
  • Critical review and gap analysis of submissions
  • Genotoxic impurities strategy
  • FDA interactions
  • Due diligence
  • Planning, strategy and interpretation of IND enabling studies
  • Clinical pharmacology and GLP TK report writing
  • Gene therapy and device challenges
  • 505(b)(2) pathway
  • Carcinogenicity study planning, strategy and interpretation

For more information, please contact:  Hilary Sheevers or Bob Guttendorf.