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Panacea

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AI-Native FDA Regulatory Services

Spring 2026Founded 20262 peopleSan Francisco, CA, USA
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AI insightcan contain mistakes
FDA Regulatory ServicesServicesBiotech and medical device companiesMedium competition
Moat
Expert hiring and outcome-based pricing create defensibility; regulatory relationship lock-in compounds advantage.
Key risk
Regulatory bodies tightening AI-generated document acceptance could reduce service value.
Why now
Biopharma companies under cost pressure seek faster, cheaper FDA approval pathways enabled by AI.
Competitors
Tufts Center, Traditional regulatory consultants

About

Panacea provides AI-native FDA regulatory services for Biotechs and Medical Device companies. We hire the most experienced FDA consultants in the industry (ex-FDA, decades of experience, hundreds of filings) and pair them with our AI platform to enable the fastest and lowest cost pathway to FDA approval. While other regulatory consultants bill hourly, our pricing model is simple: fixed, outcome-based pricing. Payment is only due when milestones are complete. We support all FDA regulatory pathways including IND, NDA, BLA, ODD, Pre-Subs, 510(k), De Novo, PMA, IDE, BDD, etc.

Founders · 2

Haris Javed-Akhtar
Haris Javed-AkhtarFounder & CEO
Microsoft🎓 Imperial College

ex-GTM (Partnerships Lead) @ Anterior - backed by Sequoia, NEA and Microsoft AI's CEO. MD, Imperial College Medical School, Imperial College Business School.

Yaman Ziadeh
Yaman ZiadehFounder & CTO

Founder & CTO at Panacea (YC P26). Previously AI Platform Engineer at Anterior, building AI infrastructure for health insurers with millions of members. Co-founded Baqi, scaling to $3M+ in transactions and 20+ enterprise partnerships. Built large-scale distributed systems at Bloomberg, leading multi-team regulatory compliance projects. BS/MS in CS and AI from UIC.

HealthcareHealthcare ServicesB2BMedical DevicesBiotechHealthcareAI

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