ORPHERA Compass

Your Regulatory Roadmap,
Before You Commit.

Enter a drug and a rare disease. Get a comprehensive regulatory pathway analysis — ODA eligibility, 505(b)(2), Breakthrough Therapy, Fast Track, and more — with a clear recommended strategy.

$800 per analysis
Order Now →
Sample Output
What your regulatory map looks like.

Sirolimus × Progeria (HGPS)

Regulatory Pathway Analysis — Generated April 2026

Orphan Drug Designation

Eligible
US prevalence <400 patients
Existing ODD Lonafarnib (granted)
Additional ODD possible Yes — different MOA

505(b)(2) Pathway

Strong Fit
Reference drug Rapamune (Pfizer)
Safety data available Extensive (20+ years)
New indication bridge study Required — efficacy

Breakthrough Therapy

Possible
Unmet medical need High
Preliminary evidence Phase 1/2 data exists
Substantial improvement Needs demonstration

Rare Pediatric Disease

Eligible
PRV eligibility Yes
PRV market value ~$100–150M
Pediatric exclusivity Applicable

Recommended Strategy

Pursue 505(b)(2) with ODD + Rare Pediatric Disease designation. Reference Rapamune safety data. Bridge study focused on HGPS-specific efficacy endpoints. PRV potential adds $100–150M in non-dilutive value. Breakthrough Therapy designation should be attempted after Phase 2 data readout.

Full report includes: timeline estimates, cost projections, precedent analysis, risk factors, 20+ page detailed strategy
Deliverable
Every analysis covers six pathways.
✓

Orphan Drug Act Analysis

ODD eligibility, existing designations, 7-year market exclusivity assessment, tax credit applicability.

✓

505(b)(2) Feasibility

Reference drug identification, safety data availability, bridge study requirements, timeline and cost estimates.

✓

Expedited Programs

Breakthrough Therapy, Fast Track, Accelerated Approval, Priority Review eligibility assessment for each.

✓

PRV & Incentives

Rare Pediatric Disease PRV eligibility, voucher market valuation, pediatric exclusivity, IRA exemption analysis.

✓

Precedent Analysis

Similar drug–disease pairs that succeeded or failed in regulatory review. Lessons learned and risk factors.

✓

Recommended Strategy

Optimal pathway combination, estimated timeline, budget range, key milestones, and decision gates.

Process
Three steps. Five business days.
1

Submit & Pay

Enter your drug–disease pair and any known regulatory context. Complete $800 payment via PayPal.

2

Analyze

Our team maps every applicable regulatory pathway, cross-referencing FDA databases, precedent cases, and current guidance documents.

3

Deliver

You receive a comprehensive Regulatory Pathway Report — with a clear recommended strategy and actionable next steps.

Order
Map your regulatory path.
Generic name preferred. Include mechanism of action if known.
Include OMIM number or gene if known (e.g. LMNA, OMIM #176670).
Payment
Regulatory Pathway Analysis × 1 $800
🔒 Secured by PayPal. Delivery within 5 business days.

You'll be redirected to PayPal for secure payment ($800). Analysis begins immediately upon payment. Delivery within 5 business days.

FAQ
Common questions.
What exactly do I get?
A 20+ page PDF report analyzing every applicable regulatory pathway (ODA, 505(b)(2), Breakthrough, Fast Track, Accelerated Approval, PRV), with a recommended strategy, timeline estimate, and precedent case analysis.
How is this different from Evidence Pack?
ORPHERA Signal tells you WHETHER to pursue a drug–disease pair (Go/No-Go). ORPHERA Compass tells you HOW to pursue it through regulatory approval. They're complementary — many clients order both.
Is this a substitute for regulatory counsel?
No. ORPHERA Compass provides strategic intelligence and pathway mapping. Formal regulatory submissions should involve qualified regulatory affairs professionals. Our report gives you the information to have more productive conversations with your regulatory team.
What jurisdictions do you cover?
Primary focus is US FDA pathways. EU (EMA) and Korea (MFDS) orphan drug pathways are available as add-ons ($200 each). Select during checkout or contact us.
How long does delivery take?
5 business days from payment. Rush delivery (3 business days) available for an additional $200.
Can I order a bundle with Evidence Pack?
Yes. ORPHERA Signal ($2,000) + ORPHERA Compass ($500) bundle pricing available — contact us. Contact us or mention "Bundle" in the context field.