The senior consultants at Aclairo® have extensive experience evaluating and advising on 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 Toxicology Services include:
- FDA and International toxicology strategy
- 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
- 505(b)(2)
- Carcinogenicity study planning, strategy and interpretation
For more information, please contact: Hilary Sheevers (hsheevers@aclairo.com) or Susan Wilson (swilson@aclairo.com)