Zuellig Pharma


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		Zuellig Pharma Specialty Solutions Group Pte Ltd 15 Changi North Way #01-01 Singapore 498770 Tel. +65 6546 8188 Fax. +65 6546 8288 Email

Patient safety | Quality assurance | Regulatory compliance | Budget reliability | Timely distribution

Asia is now an important R&D base for drug, vaccine and medical device testing. Sponsors and CROs seek faster patient recruitment to reduce study timelines, target ethnic diversity for higher product safety and efficacy testing. Cost reductions arise from shorter study time and faster product registrations.

Extending from Zuellig Pharma’s long experience in clinical trials and drug study logistics, SSG offers a fully certified, GCP compliant and highly controlled regional Clinical Trials Management (CTM) solutions portfolio. Our comprehensive pan-Asia network of in-country depots offers efficient, cost-effective distribution solutions from IP supplier to study subjects.

CTM project managers evaluate central and local depot options to meet protocol requirements in terms of drug availability, quality, safety, time and cost. Our team consults with Zuellig Pharma in-country depots and their regulatory specialists to implement compliant and optimal processes for specimens and kits. SSG’s freight management offers traceability and visibility throughout. Central or local depots have dedicated and access-restricted areas for CTM, providing a secure, segregated and confidential environment for study management within a zero-defect operation. Together our team ensures quality in trial management, storage and value-added services, including kitting, labeling, and packing. As a door-to-door service, we handle collection and shipment of specimens and samples from study sites to the appointed central labs. The result is a CTM solution with maximum reach to and from all countries across Asia.

SSG expertise ranges from open label to blinded and randomized trials. Cold-chain shipper boxes have been validated and are available in several configurations.

SSG’s IT division is 21 CFR Part 11 compliant in relation to US FDA regulations which ensures traceability of serial and lot number. This also facilitates accurate management along with returns/recalls.

Regional depot model I
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Local depot model II
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"Leveraging experience, reaching further"

List of Services

Central Depot (Singapore)

Local Depot options (8 locations)

Project management (central/local)

Secure dedicated CTM storage

< 25°C

2 - 8°C

- 20°C

Controlled drug

CTM distribution services

Bulk shipment

Just-in- time to sites

Specimens

International

Local

In-house regulatory pharmacists

License/permit application

CTM returns and destruction services

Controlled Drug management

Secondary Labeling/Packaging/Kitting

Validated cold chain solution

Controlled ambient < 25°C

2 - 8°C

- 20°C

Vendor selection

Comparator sourcing

Certified Operations

ISO9001

GMP

GSDP

Manufacturing License

GCP compliant (storage & distribution)

US FDA 21 CFR Part 11 compliant