About
Dr. Felicity Mercer brings 22 years of regulatory expertise spanning FDA and academia. She has guided over 30 peptide therapeutic candidates through pre-IND to Phase III regulatory submissions.
Summary
Former FDA peptide drug reviewer who now helps academic and industry teams navigate complex regulatory pathways.
Key Lessons
A rejected IND application early in her career taught her that specification setting for peptide related substances requires proactive, data-driven justification rather than default compendial limits.
Certifications
- Ph.D. Regulatory Science, Johns Hopkins
- RAPS Fellow
- Former FDA Reviewer
Areas of Expertise
- Peptide IND filings
- ICH compliance
- GMP audit preparation