Services
A precise compliance toolkit for botanical extract manufacturers.
Five integrated disciplines that bring international facilities into alignment with US FDA expectations — practical, documented, and audit-ready.
Scoped. Practical. Built for inspection.
Each engagement is scoped to your facility, product class, and target US channel — supplements, food ingredients, or both.
01.
FSMA Documentation Support
Food Safety Modernization Act compliance, end to end.
- Hazard Analysis and Risk-Based Preventive Controls (HARPC)
- Food Safety Plans tailored to botanical extracts
- Supply chain preventive controls and supplier verification records
- Recall plans, monitoring records, and corrective action documentation
02.
cGMP Quality System Preparation
Current Good Manufacturing Practice systems built for the realities of botanical processing.
- Master Manufacturing Records and Batch Production Records
- SOPs for sanitation, equipment, personnel, and process controls
- Identity, purity, strength, and composition specifications
- Out-of-specification investigations and CAPA frameworks
03.
FSVP Program Development
Foreign Supplier Verification Programs that withstand FDA scrutiny.
- Importer-of-record evaluation and DUNS support
- Hazard reviews, supplier approvals, and verification activities
- Annual reassessments and corrective action protocols
- Recordkeeping systems aligned with 21 CFR Part 1 Subpart L
04.
FDA Registration Assistance
Facility registration, US Agent services, and regulatory correspondence.
- Initial and biennial facility registration
- US Agent representation for foreign facilities
- Prior Notice filings and import compliance support
- Communication management with FDA district offices
05.
Audit Preparation & Documentation
Be ready before the inspector arrives.
- Mock FDA inspections and observation simulations
- Document remediation, gap closure, and SOP refinement
- Front-room and back-room inspection coaching
- 483 response strategy and Warning Letter remediation
Custom scope
Need something beyond this list?
We regularly support label review, COA template design, allergen control, and dietary supplement-specific requirements under 21 CFR 111. Tell us what you need.
Why it matters
Why a strengthened quality system matters.
A robust quality system is not paperwork — it is the operating evidence that your product is safe, identifiable, and reproducible every single batch. For botanical extract powders, that evidence is what stands between your shipment and a US border hold, an import alert, or a 483 observation.
Strengthened systems shorten FDA inspections, simplify customer audits, accelerate onboarding with US brand owners, and protect the reputation you have built across decades of botanical craft.
At QualioRa, we don’t just prepare documents — we build systems that sustain compliance and protect your business reputation.
Why QualioRa
Built on dual expertise. Tuned for botanicals.
01
Dual expertise
Quality assurance and regulatory affairs under one roof — no handoffs, no translation loss.
02
Botanical extract focus
Specialisation in herbal and botanical extract powders, not generic food manufacturing.
03
International facility fluency
Deep experience with manufacturers in India, China, and across Asia preparing for US entry.
04
US-based compliance partner
A qualified individual on US soil — accessible to FDA, importers, and brand owners alike.
05
GMP + FSMA + FSVP alignment
Three frameworks designed and maintained as a single coherent compliance architecture.
06
Audit-tested approach
Systems built for inspection-day performance, not just shelf appeal.
SERVICE TIMELINE
A clear, step-by-step journey
to
compliance confidence.
01
Discovery
& Requirement
Mapping
We begin with a structured consultation to understand your product category, regulatory status, supplier details, and compliance gaps.
02
Document Review
& Gap
Assessment
We review your existing documents (COAs, SOPs, supplier files, HACCP, GMP records) and identify what is missing or non compliant.
03
Compliance
Plan &
Deliverables
You receive a clear, actionable plan outlining required a documents, timelines & responsibilities aligned with FDA, FSMA, and FSVP requirements.
04
Implementation & Documentation
Development
We will prepare, refine, and organize all required documents, including SOPs, hazard analyses, supplier verification files, audit checklists, and registration submissions.
05
Final Review,
Approval
&
Handover
You receive a complete audit ready compliance package with all required records, templates, and guidance for ongoing maintenance.
Structured. Transparent. Built for compliance that lasts.
Our process is designed to give you clarity at every step and deliver a robust compliance foundation that supports long-term operational confidence.