What We Offer

Services

Beyond distributing world-class packaging products, TSS provides the regulatory expertise, technical support, and logistical flexibility that pharmaceutical companies in Korea need to move faster from R&D to market.

Our Services

How We Support Your Programme

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Import & Domestic Supply

TSS imports, distributes, and supplies primary packaging products from our three world-class global partner manufacturers directly to pharmaceutical companies across Korea.

Stable, reliable supply from ISO 15378 and ISO 13485 certified partners
Flexible order quantities — from R&D trial packs to full commercial batches
Import documentation, customs clearance, and local warehousing support
Just-in-time delivery to reduce your inventory burden

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Regulatory & GMP Consulting

Our team includes a former MFDS Senior Deputy Director with 26 years of government regulatory experience — providing authoritative guidance that most packaging distributors simply cannot offer.

Korean MFDS regulatory submission support for packaging change controls
FDA, EMA, and ICH Q12 compliance guidance
GMP documentation preparation and review
Packaging-related regulatory strategy for IND, NDA, and ANDA applications
EP 3.2.9, USP <660>, JP 7.03 compliance documentation

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Sample Support

TSS supplies trial samples for clinical-stage development and auxiliary material change studies — covering everything from first-in-human studies to commercial packaging qualification.

Clinical-stage component samples with full documentation
Auxiliary material change (부자재 변경) trial sets
Small-scale matched component sets for R&D and formulation development
Rapid turnaround for urgent project timelines
Four tax-invoiced clinical sample deliveries to major Korean pharma companies (Aug–Sep 2025)

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Technical Support

Working closely with our partners' specialist teams, TSS provides hands-on technical support across the full packaging selection, validation, and fill-finish integration process.

Product selection guidance based on drug product characteristics
Drug-container compatibility assessment support
Fill-finish line integration consulting
Expert collaboration with partner company technical specialists
Real-time updates on product specifications and regulatory changes

Regulatory Expertise

Where Packaging Expertise Meets Regulatory Authority

TSS is uniquely positioned — our team combines 30 years of pharmaceutical packaging technical sales with 26 years of government regulatory service at MFDS and MAFRA.

30+

Years packaging industry expertise in Korea's pharma market

Years government regulatory service (MFDS & MAFRA)

200+

Korean pharma companies served across the team's combined career