Executive Regulatory Support

Let's align on your FDA strategy.

Direct access to founder-led infrastructure for market entry, U.S. Agent representation, and portfolio governance.

Complete the brief intake below to define scope. We typically respond within 1 business day.

Start the intake briefing ↓
 
 
Intake form
~ 2 minutes to complete
Share the essentials so we can confirm scope, fees, and timelines; NDAs and document exchange come after engagement is confirmed.
What to include
  • Your company, device type, and target U.S. timeline.
  • The service needed.
 
 
Submit your details
Secure intake
In one sentence, describe what the device does, where it is used (e.g., OR, ICU, EMS), and who it is used on (adult, pediatric, neonatal). Include any key attributes (sterile/non-sterile, single-use/reusable, patient-contact, software-driven) if you know them.
If multiple sites, list the primary site for FDA registration
In 3–5 sentences, tell us what you’re trying to achieve and what’s blocking you (e.g., new registration, device listing updates, U.S. Agent coverage, portfolio clean-up). Do not include PHI/patient identifiers or confidential attachments.
Response target: within 1 business day for complete submissions.
Headquarters
9105 E 56th St, Ste J #2057
Indianapolis, IN 46216
Direct Line
+1 (317) 662-0910
Mon–Fri, 9am–5pm EST
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Existing client support, admin, or IT requests.