FDA / CGMP Compliance
Medical gas, CGMP, quality systems, documentation, inspection readiness, and FDA registration management.
Medical gas companies operate under FDA requirements that affect how product is manufactured, documented, and released. AsteRisk works with medical gas companies on the CGMP and FDA compliance realities of day-to-day operations — not just the regulatory language.
Your FDA registrations are our job to track, not yours
Food facility registration. Drug establishment registration. Device registration. Annual renewals and attestations, on top of CARES Act reporting — if your gas business touches FDA-regulated products, the registration calendar never really stops. As GAWDA's official FDA consultants, we track and manage these registrations for our clients so nothing lapses without warning.
Every registration tied to your FDA-regulated products, managed under one roof
Food Facility Registration
Registered and renewed through FDA's FURLS system, tied to your DUNS number, so a new location or ownership change doesn't create a gap.
Drug Establishment Registration and Drug Product Listing
FEI number assignment, establishment registration, and drug listing renewals managed through CDER Direct.
Device Establishment Registration
Device registrations tracked alongside your other FDA filings, not managed separately and forgotten.
CARES Act Reporting
Annual Drug Amount Information reports filed through the CDER NextGen Portal, on time, every year.
Annual Reports (NDA/NADA Holders)
The Annual Report for original manufacturers, coordinated with the CARES Report for streamlined compliance.
State Licenses & Permits
State licenses and permits, including drug and wholesale, processed alongside your federal filings.
When a client falls behind, we bring them back
We've helped clients recover from lapsed registrations and catch up years of overdue CARES Act reporting — recovering CDER Direct access, resolving validation issues, and getting them fully current with no disruption to their business.
Have a specific FDA or CGMP question?
The fastest way to get an answer is to talk to someone directly. Tell us what you're working on and we'll point you to the right person or resource.
Talk to an Expert