Panacea
Panacea is an AI-native FDA regulatory consulting firm combining ex-FDA experts with custom AI tooling to accelerate medical device and biotech submissions. It serves life sciences companies across 510(k), De Novo, PMA, IND, NDA, and BLA pathways via fixed, milestone-based engagements.
- Company typePrivate
- Founded2026
- HeadquartersSan Francisco, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Panacea does
Panacea is an AI-native FDA regulatory consulting firm based in San Francisco that combines a team of ex-FDA regulatory experts with custom AI tools to accelerate U.S. medical product approvals. The company supports life sciences clients across the full spectrum of FDA pathways — 510(k), De Novo, PMA, IND, NDA, and BLA — offering services spanning regulatory strategy and roadmap development, pre-FDA meeting support, end-to-end submission authoring, and quality system buildout. Its core technology positioning centers on proprietary, domain-specific AI workflows for predicate research, evidence mapping, submission structure, and technical narrative development, with the company claiming 60% faster delivery than traditional regulatory consulting firms and 100% expert oversight on all deliverables.
The company's go-to-market is sales-led and direct-to-enterprise, acquiring customers through free consultation bookings and content marketing via its website (withpanacea.com) and LinkedIn presence. Its business model is professional services with a distinctive fixed, milestone-based pricing structure — clients pay only when defined deliverables are completed rather than on hourly billing — applied to multi-year engagement contracts that align incentives across the FDA approval cycle. Its primary customer segment is medical device companies (startups to established MedTech firms), with biotech and pharma as a secondary segment for drug submission pathways.
Panacea is a privately held, founder-led company at seed stage with 1-10 employees. It raised $500,000 from Y Combinator in June 2026 and made a strategic co-investment in OutSee's £2.5M seed round in January 2026. Public customers disclosed include Adialante (mobile MRI 510(k)) and Acoustic Wave Cell Therapy (AWCT) (acoustic pulse therapy 510(k)). The senior regulatory figure is Dr. Jin Zhang, PhD, a former FDA Lead Reviewer and Team Lead serving as Principal Regulatory Affairs, with founders Haris Akhtar (CEO) and Yaman Ziadeh (CTO) leading the company.
Panacea firmographics
Firmographics- Name
- Panacea
- Legal name
- Panacea
- Website
- https://withpanacea.com
- Company type
- Private
- Founded year
- 2026
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Panacea is an AI-native FDA regulatory consulting firm combining ex-FDA experts with custom AI tooling to accelerate medical device and biotech submissions. It serves life sciences companies across 510(k), De Novo, PMA, IND, NDA, and BLA pathways via fixed, milestone-based engagements.
- Ownership category
- akta.pro rank
Panacea industry classification
Industry- Product category
- FDA Regulatory Consulting
- NAICS
- Software Publishers (5132)
- SIC
- Services-Prepackaged Software (7372)
- akta.pro primary industry
- Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH)
- akta.pro secondary industry
- Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH)
Keywords
Where Panacea is headquartered
LocationHeadquarters
- HQ city
- San Francisco
- HQ country
- United States
- HQ region
- North America
Markets served
Panacea business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales
Revenue model
- Regulatory Consulting Services: Panacea generates revenue through milestone-based regulatory consulting engagements. Clients pay only when defined deliverables are completed, aligning incentives between the company and clients. No hourly billing. The company works on fixed pricing agreements scoped to specific regulatory milestones and timelines.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Outcome Based/ Performance | Multi-year contract | Milestone-Based Fixed Pricing |
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
Panacea product offering
Product offeringCore offering
Panacea delivers AI-accelerated FDA regulatory consulting services that combine ex-FDA regulatory experts with proprietary AI tools to author and submit 510(k), De Novo, PMA, IND, NDA, and BLA filings. The company sells milestone-based fixed-price engagements to medical device and biotech companies, covering regulatory strategy, pre-submission engagement, full submission authoring, and quality system buildout.
Product overview
Panacea is a unified AI-native FDA regulatory platform combining ex-FDA regulatory experts with specialized AI technology. The platform integrates four core service modules: Expert-led Strategy (regulatory pathway definition and planning), End-to-end Support (full submission lifecycle management), FDA-trained AI (purpose-built AI tools for regulatory workflows), and Risk-free Pricing (fixed milestone-based billing). These components work together to deliver accelerated FDA approval across 510(k), De Novo, PMA, IND, NDA and BLA pathways.
Differentiator
Problem solved
Functional benefit
Products and services
- Panacea AI-Native FDA Regulatory Services End-to-end AI-accelerated FDA regulatory consulting service covering strategy, pre-submission engagement, full submission authoring, and quality system buildout across 510(k), De Novo, PMA, IND, NDA, and BLA pathways, delivered under fixed milestone-based pricing for medical device and biotech companies.
- Expert-led Regulatory Strategy Regulatory pathway definition and milestone-driven roadmap development delivered by ex-FDA consultants with decades of combined experience across all device types, helping clients choose between 510(k), De Novo, PMA, IND, NDA, and BLA pathways.
- End-to-End FDA Submission Support Full lifecycle submission support from pre-FDA meetings through end-to-end authoring and final submission, covering 510(k), De Novo, PMA, IND, NDA, and BLA filings with constant expert oversight and AI-accelerated drafting.
Quantifiable outcome
- 60% faster delivery than traditional regulatory consulting firms
- +1 more outcomes
Companies that use Panacea
Customer profileNamed customers2 records
Segments2 records
Ideal customer profiles2 records
Panacea technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability3 records
Feature3 records
Panacea partnerships and signals
Strategic signalScale indicators3 records
Recent moves5 records
Expansion highlights5 records
Panacea competitors and assessment
Company assessmentBroad incumbents
- Charles River Laboratories: Major CRO providing regulatory, safety, and submission support across pharma and biologics. Represents the established scale player competing for the same IND/NDA/BLA work.
- Medpace: Mid-to-large CRO with regulatory affairs and clinical submission capabilities for pharma/biotech. Overlaps with Panacea's IND/NDA/BLA pathway support.
- ICON plc: Global CRO offering full-service regulatory consulting and submission services. Comparable as a large, diversified alternative for life sciences regulatory work.
- IQVIA: Global CRO with a large regulatory affairs and drug submission practice covering IND/NDA/BLA. Broad incumbent alternative to Panacea for biotech/pharma clients.
Direct peers
- Rimsys: Regulatory affairs management software and services for medical device and diagnostics companies. Directly comparable to Panacea's AI-driven FDA submission tooling and targets the same 510(k)/PMA workflow.
- Greenlight Guru: Quality management and regulatory workflow platform purpose-built for MedTech, including 510(k) and design control support. Closest SaaS-style competitor to Panacea's AI workflow platform.
- MethodSense: Regulatory and quality consulting firm for medical device, IVD, and combination product companies. Competes with Panacea's regulatory consulting and submission-authoring services.
Emerging players
- Proxima Clinical Research: Specialty CRO focused on medical device and biotech regulatory strategy and clinical trial execution. Niche emerging competitor in the same FDA submission space.
- StarFish Medical: Medical device design and regulatory services firm supporting 510(k), IDE, and PMA submissions. Comparable as a focused device-pathway regulatory specialist.
- Clarus Networks (regulatory consulting): Specialized regulatory consulting firm supporting medical device and pharma companies with FDA submissions. Comparable scope to Panacea's regulatory strategy and authoring services.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
Panacea social profiles
Digital presencePanacea financial estimates
Financial estimateRevenue estimate
Valuation estimate
Panacea leadership team
Management profileNumber of profiles
Profiles3 records
Panacea funding detail
Funding detailFunding overview
Funding rounds1 record
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Panacea M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Panacea
What does Panacea do?
Panacea delivers AI-accelerated FDA regulatory consulting services that combine ex-FDA regulatory experts with proprietary AI tools to author and submit 510(k), De Novo, PMA, IND, NDA, and BLA filings. The company sells milestone-based fixed-price engagements to medical device and biotech companies, covering regulatory strategy, pre-submission engagement, full submission authoring, and quality system buildout.
Is Panacea a public or private company?
Panacea is a private company. It is classified as venture growth investor backed and is currently operating.
When was Panacea founded?
Panacea was founded in 2026. It employs 1 to 10 people.
Where is Panacea based?
Panacea is headquartered in San Francisco, United States, in the North America region.
How does Panacea make money?
One revenue line is on record: regulatory Consulting Services.
Who are Panacea's main competitors?
Broad incumbents on record are Charles River Laboratories, Medpace, ICON plc and IQVIA. Direct peers are Rimsys, Greenlight Guru and MethodSense. Emerging players are Proxima Clinical Research, StarFish Medical and Clarus Networks (regulatory consulting).
Does Panacea have an API?
No public API is recorded for Panacea.
What industry is Panacea in?
Panacea's product category is FDA Regulatory Consulting. Its primary akta.pro industry code is HLAIALAH, Regulatory Strategy & IND/NDA/BLA Submissions Support, with a secondary code of HLAGAAAH, Pharmacovigilance, Risk Management & Medical Affairs CROs. Its NAICS code is 5132 and its SIC code is 7372.