FDA Compliance · Botanical Extracts
Compliance,
cultivated for the US
market.
QualioRa partners with international botanical extract manufacturers to navigate FDA requirements — from FSMA and cGMP to FSVP, registration, and audit readiness.
Standard
Framework
Programs
Reg. No.
WHAT WE DO
End-to-end FDA compliance,
built for botanical manufacturers.
Each engagement is scoped to your facility, product class, and target US
channel — supplements, food ingredients, or both.
FSMA Documentation
Support
Food Safety Modernization Act compliance, end to end — HARPC, supplier verification, recall plans.
cGMP Quality
System Prep
Manufacturing records, SOPs, batch records, and CAPA frameworks for botanical processing.
FSVP Program
Development
Foreign Supplier Verification Programs that withstand FDA scrutiny — importer evaluation, hazard reviews.
FDA Registration
Assistance
Facility registration, US Agent services, Prior Notice filings, and FDA correspondence.
Audit Preparation &
Docs
Mock FDA inspections, 483 response strategy, front/back-room coaching and Warning Letter remediation.
Not sure where to
start?
Every service. One compliance partner.
Scoped to your facility, product class, and US market channel.
METHODOLOGY FRAMEWORK
How an engagement unfolds— from first call to audit-ready handover.
Every QualioRa partnership follows a predictable five-stage path.No surprises, no ambiguity — a documented trail from diagnosis to a complete compliance package your team can sustain
01
Discovery
Structured consultation to map product category, regulatory status, supplier network, and current compliance posture.
02
Gap Assessment
Forensic review of existing COAs, SOPs, supplier files, HACCP and GMP records — what’s missing, what’s misaligned.
03
Compliance Plan
A clear, dated roadmap: deliverables, owners, and timelines anchored to FDA, FSMA, and FSVP requirements.
04
Implementation
We draft and refine SOPs, hazard analyses, supplier verification files, audit checklists, and registration submissions.
05
Handover
A complete, audit-ready compliance package with records, templates, and guidance for ongoing maintenance.
Predictable
Fixed stages, documented deliverables, no scope drift.
Evidence-led
Every recommendation tied to a CFR clause or FDA guidance.
Sustained
We hand over a system your team can run — not a binder that ages.
Brand Principles
QUALIORA — Eight letters,
one operating philosophy.
Q
Quality
GMP Excellence
u
Understanding
Insight & Analysis
A
Accountability
Traceable Compliance
l
Leadership
Regulatory Guidance
i
Integrity
Ethical Standards
o
Operational
Efficient Solutions
r
Reliability
Consistent Support
a
Alignment
Global Compliance
ABOUT QualioRa
How we turn botanical expertise into FDA-ready systems.
QualioRa exists because international botanical manufacturers deserve a compliance partner that speaks both the language of FDA and the realities of herbal extraction.
Focus
Botanicals
Market
United States
01
Documented, not improvised
Every system we deliver is paper-trail ready. If it isn’t written down, FDA considers it didn’t happen.
02
Botanical-first expertise
We don’t generalise across food categories. Our specialists know herbs, extracts, and the unique controls they require.
03
Built for inspection
We design systems that perform under regulator scrutiny — not just on paper, but in front-room and back-room scenarios.
04
Sustainable compliance
Compliance is not a project. We architect QMS that your team can run, evolve, and defend long after engagement ends.
Ready to build an FDA-ready system?
Tell us about your facility, and we’ll map your compliance pathway.
Still have questions?
Speak with a specialist directly.
A working knowledge base on FDA compliance for botanical extracts. If your question isn’t here, ask us directly.