Compliance built in. Not added on.
Quality isn't a checkbox for us — it's the foundation we've built every client relationship on since 1999. Here's a clear look at our registrations, process validation, serialization, supplier controls, and recall readiness.
Six credentials that qualify us before the call.
All active. All third-party verified. All available on request with reg numbers and issue dates.
FDA Registered
Registered establishment under 21 CFR Part 207. Included in the FDA's Drug Establishment Database.
cGMP Compliant
Current Good Manufacturing Practice per 21 CFR Parts 210 & 211 for pharmaceuticals. Full validation stack maintained.
Quality manual: available on NDA
DSCSA Capable
Full Drug Supply Chain Security Act Phase 3 compliance. Unit-level serialization, full aggregation, T3 interoperability.
Genealogy: raw → unit → case → pallet
SQF Level 2
Safe Quality Food Level 2 certification, GFSI-recognized, for secondary packaging and co-packing operations serving CPG.
Scope: secondary packaging, kitting
ISO 9001
Quality Management System certified to ISO 9001:2015 — third-party audited documentation, process control, and corrective action discipline.
CPA Member
Contract Packaging Association member in good standing. Peer-audited industry network for regulated packaging operations.
Validated processes. Documented outcomes.
We validate prospectively for new products and maintain continued process verification on commercial runs. Every deviation is captured, investigated, and closed in the QMS.
Prospective validation
Three-batch PPQ (Process Performance Qualification) for every new product. Statistical capability demonstrated before commercial release.
Continued process verification
Every commercial run trended against validated parameters. SPC charts reviewed at batch release. Out-of-trend = investigation trigger.
Cleaning validation
Swab and rinse studies for every shared-equipment campaign. Validated cleaning procedures re-qualified on cadence.
Equipment qualification
IQ/OQ/PQ lifecycle maintained on every critical system. Change control required before requalification-impacting modifications.
End-to-end product traceability.
Every serialized product carries a verifiable trail from component receiving through finished pallet dispatch. We serialize, aggregate, and report under full DSCSA Phase 3 rules.
Unit-level serialization
Line-level printing and verification of GS1 SGTIN serial numbers on every primary container. 100% read-verified at print.
Aggregation
Parent-child relationships built live: unit → carton → case → pallet. Full hierarchy transmitted with every shipment.
L4 connections
Live connections to TraceLink, Systech, rfxcel, TTRx, LSPedia, and Cardinal 3PL — and through TTRx, to any other L4 provider.
Batch genealogy
Raw component lot → API → finished unit serial → aggregated case → shipped pallet. Fully queryable audit trail retained per regulation.
We test every active. Every time.
Certificates of Analysis are a starting point, not a substitute. Identity testing runs on every active ingredient inbound — no shortcuts, no exceptions.
Identity testing on every active
Every active ingredient receives identity confirmation (FTIR / HPLC) on receipt. No release to production without positive ID.
Supplier qualification program
Initial document review → audit → qualification batch → ongoing re-evaluation based on risk tier. Approved Vendor List maintained.
Excipient risk-based testing
Excipient testing scope determined by risk assessment. Higher-risk materials receive additional assay / impurity testing beyond CoA.
Quarantine and release controls
All received materials held in quarantine until QA release. Status-controlled warehouse with labeled segregation.
Mock-tested. Sub-24-hour response.
The question isn't whether a recall will ever happen. It's whether your packager can move fast enough when it does. Ours is tested annually, with documented response-time metrics.
Annual mock recall
Documented mock recall performed every 12 months. Response-time metric recorded, gaps addressed in corrective action.
Sub-24-hour pallet query
Pallet-level recall query returned within 24 hours. Full batch genealogy produced on demand with verified chain of custody.
Client notification protocol
Documented escalation paths for recall-impacting events. Designated client point-of-contact notified within the committed SLA.
Distribution records retention
Full shipment records retained per 21 CFR § 211.196 and DSCSA retention rules. Historical lookback queryable for the full regulatory window.
Our quality manual is available on NDA.
Compliance teams that need full documentation before a call — SOP inventory, validation plans, audit history, CAPA summaries — can request the quality manual directly. We'll send it with the NDA for signature.
Request Quality ManualTwo ways to vet us before you share your request.
Schedule a 30-minute compliance walkthrough.
Bring your compliance team. Ask us anything. We'll screen-share the QMS dashboard, review audit history, and answer the questions your request doesn't ask.
Schedule WalkthroughDownload the capabilities brief.
Services, equipment inventory, certifications, run-size ranges — in a single PDF for your vendor qualification file.
Download Brief