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PKG-ESTIMATOR v3.1 // LIVE

Packaging Cost Estimator

Configure your dosage form, volume, and compliance requirements. Results update in real time.

SYS: NOMINAL|FDA 21 CFR COMPLIANT
01 /Dosage Form
02 /Annual Unit Volume1.0M units/yr
100K50M
PHASE I/IISCALE-UPCOMMERCIAL
03 /Compliance Requirements
Live Output
RESULTS REFRESH ON CHANGE
AWAITING CONFIGURATION
SELECT DOSAGE FORM TO BEGIN

1/3 FIELDS COMPLETE

◆FDA 21 CFR Part 211 Compliant◆99.97% First-Pass Audit Rate◆ISO 15378 Certified◆DSCSA Track & Trace Ready◆GMP-Validated Cleanroom Class 100K◆2.4B Units Serialized◆ICH Q10 Pharmaceutical Quality System◆USP <1> Tamper-Evident Standards◆FDA 21 CFR Part 211 Compliant◆99.97% First-Pass Audit Rate◆ISO 15378 Certified◆DSCSA Track & Trace Ready◆GMP-Validated Cleanroom Class 100K◆2.4B Units Serialized
FDA Audit Performance // YTD 2026
99.97%
First-Pass FDA Audit Rate
Across 6,383 regulatory submissions · 2019–2026
Breakdown Below
AUDIT BREAKDOWN // BY CATEGORY

Every category. Every submission. On record.

SER-TT
PASS
99.98%
Serialization & Track-Trace
1,247 audits
CRC-16
PASS
100.00%
Child-Resistant Closure
892 audits
TEI-01
PASS
99.96%
Tamper-Evident Integrity
1,103 audits
SBS-ISO
PASS
99.94%
Sterile Barrier System
634 audits
CCV-2C
PASS
99.99%
Cold-Chain Validation
418 audits
LBL-CFR
PASS
100.00%
Label Compliance (21 CFR)
2,089 audits
6,383Total SubmissionsYTD 2026
2Resubmissions Required0.03% rate
11.4 daysAvg. Review Cyclevs. 34d industry avg.
Global Serialization Network // Active
2.4B
Units Serialized Globally
Across 6 distribution nodes · 4 regulatory jurisdictions · 3 continents
DISTRIBUTION NODES // REAL-TIME STATUS

Supply chain coverage engineered for no single point of failure.

PHILADELPHIASAN DIEGOBASELSINGAPOREMUMBAISÃO PAULO
USA
Philadelphia
820M units/yr
USA
San Diego
310M units/yr
Switzerland
Basel
490M units/yr
SGP
Singapore
380M units/yr
India
Mumbai
280M units/yr
Brazil
São Paulo
120M units/yr
Capability Stack // All Systems Green

Every compliance requirement.
Engineered in, not bolted on.

SER-001
OPERATIONAL
100%
DSCSA Compliance

Serialization & Track-Trace

2D DataMatrix + linear barcode application at 800 units/min. Full EPCIS event logging. Real-time aggregation from unit → case → pallet.

DSCSAGS1-128EPCIS 2.0EU FMD
CRC-002
CERTIFIED
16 CFR
1700 Certified

Child-Resistant Closures

Push-turn, squeeze-turn, and blister configurations. Panel testing with pediatric and senior populations on every new SKU.

PPPAISO 8317ASTM D3475
TE-003
CERTIFIED
0
Failures Since 2019

Tamper-Evident

Induction sealing, shrink banding, breakaway caps. Inline vision inspection at 100% throughput.

USP <1>21 CFR 211
CC-004
OPERATIONAL
−80°C
to +25°C Validated

Cold-Chain Packaging

Phase-change materials, vacuum-insulated panels, and PCR temperature indicators. Validated for biologics, mRNA, and frozen injectables.

ICH Q5CGDPISTA 7D
VIS-005
ACTIVE
99.999%
Defect Detection Rate

Vision Inspection

AI-powered camera systems inspect label placement, seal integrity, and barcode readability at full line speed.

21 CFR 211.68ISO 11607
DOC-006
OPERATIONAL
< 24hr
Record Release

Batch Record Automation

Electronic batch records with full audit trail. FDA 21 CFR Part 11 compliant e-signatures. Zero paper in the cleanroom.

21 CFR Part 11ICH Q10GMP
Certifications:ISO 15378ISO 11607GMP 21 CFR Part 211FDA 21 CFR Part 11ICH Q10EU GMP Annex 1DSCSA ReadyISO 9001:2015
Waste Reduction // Industry Benchmark
31%
Less Packaging Waste Than Industry Average
Based on FDA/EPA benchmarking data · Validated across 847 commercial SKUs
Primary CTA

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Configure your dosage form, annual volume, and compliance requirements in our live estimator. Cost-per-unit, timeline, and waste reduction — calculated instantly.

48hr
Quote Turnaround
$0
Estimator Cost
100%
Audit Coverage
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Resource Download
PDF
2026 FDA Packaging Compliance Checklist
47 items · Serialization · CR · TE · Cold-Chain · Label
Updated Feb 2026 · 21 CFR Part 211 Current

Download Compliance Checklist

47-point FDA packaging compliance checklist covering serialization mandates, CR closure testing, tamper-evident requirements, and cold-chain validation. Used by regulatory affairs teams at 200+ pharma companies.

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200+
Pharma Companies
Active clients
847
Commercial SKUs
In production 2026
11.4d
Avg. Review Cycle
vs. 34d industry
4hr
Response SLA
Business hours