VIRTUAL TOUR
VIDEO
SERVICE OVERVIEW CLINICAL TRIAL SUPPLIES
Primary Packaging
• Blisters
• Bottles
• Tubes
• Sachets
Packaging (Labelling)
• Wallets
• Blister cards
• Child resistant
Label Printing
• CT Labelling Software for
• Generation of Randomization Lists
• Printing of Emergency Envelopes
Manufacturing
• Over-encapsulation
• Capsules
• Tablets
• Granulation / Blending
• Oral Powders for Constitution (OPCs)
Import
• Import from Non-EU countries
• Audit of manufacturing sites
• QP Declarations
• Re-testing
QP Release
• Analytical services
• Batch release testing
Storage and Distribution
Global Depot Network
• Temperature controlled shipments
• Temperature monitoring
YOUR BENEFITS
• Significant experience
• High flexibility
• Tailor-made services
• All services under one roof
• Consultancy services
• Quick-to-Phase-1-Concept
COMPARATOR BLINDING
Overencapsulation
Harro Höflinger KFM IIIC
Tool-free tablet feed
Dosator powder filling station
100% weight control
Product specific feeds for higher throughput
Blinding Of Tubes
Blinding of Inhalers
Blinding of Inhalers
In-house Pharmaceutical Analytics
• Comparator stability
• Method development
• Method validation
PRIMARY PACKAGING
Fleximation Trialpack 600
Fleximation Trialpack 600
• Blister Robot
• Mixed blisters
• Up to 4 products
Pentapack EAS Unit Dose
• PC Controller and vision control
• Specifically laid out for small to
• High blister design flexibility with
• Thermoform blisters
• PVC-PVDC, Triplex, COC, Aclar
• Coldforming / Alu-Alu blisters
SECONDARY PACKAGING
• Patient kit assembly
• Wallet cards
• Bottles
• Tubes
• Metered Dose Inhalers
QP RELEASE
• QP Release
• Batch Release Testing
• Import
• Audit of Non-EU manufacturers
• QP Declarations for CTA
ANALYTICAL SERVICES
Our services are supported by a strong analytical group offering NUVISAN’s well-known expertise in Pharmaceutical Analytics.
• Method development
• Method validation
• Stability
• Release testing (under the shared manufacturing license of CTS)
For more details see Pharmaceutical Analytics
DISTRIBUTION SERVICES
Storage facilities
• Controlled room temperature; 800 m²
• Refrigerated storage: 75 m³ (3 chambers)
• Frozen: -20°C (3 x 2m³)
• Deep frozen: -70°C
Domestic and International Shipments
Standard scenario: 24h – request to shipment
Temerature Controlled Shipments
• Shipment geometry validation
• Validated configurations available: E.g. up to 5 days at 2-8°C
• Various active and passive configurations in regular use
Depot Network
• NUVISAN Pharma Services Deutschland
• Qualified, audited partner for:
- Argentina
- Australia
- Brazil
- Chile
- China
- Colombia
- India
- Israel
- Mexico
- Russia
- South Africa
- Turkey
- Ukraine
- United States of America
- and more
QUALITY STANDARDS
• Good Manufacturing Practice – Manufacturing and Import license
• GMP certificate
• An internal audit program strengthens the CTS and PAS departments
• To provide services that meets regulatory standards and defined product
• License for handling narcotics
• ZAB, Regierung von Oberbayern (GMP, local Agency)
• FDA (GMP inspection experience)
• QM Service for Clients / Customers
