Clinical Services

VIRTUAL TOUR

 

SERVICE OVERVIEW CLINICAL TRIAL SUPPLIES

Primary Packaging

• Blisters

• Bottles

• Tubes

• Sachets

Packaging (Labelling)

• Wallets

• Blister cards

• Child resistant

 

Label Printing

• CT Labelling Software for 
  complex study designs

• 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 
  (15-25°C, 2-8°C, -20°C, -70°C)

• 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 
2 different tablets per capsule possible

Blinding Of Tubes

Blinding of Inhalers

Blinding of Inhalers

In-house Pharmaceutical Analytics

• Comparator stability

• Method development

• Method validation

 

 

PRIMARY PACKAGING

Fleximation Trialpack 600

• Blister Robot

• Mixed blisters

• Up to 4 products

Pentapack EAS Unit Dose

• PC Controller and vision control 
  system

• Specifically laid out for small to 
  medium size blister runs

• High blister design flexibility with 
  low tooling costs

• Thermoform blisters 
  (qualified for PVC)

• 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 
  attributes in manufacturing verified by the quality control laboratory 
  (identity, strength and purity).

• License for handling narcotics

• ZAB, Regierung von Oberbayern (GMP, local Agency)

• FDA (GMP inspection experience)

• QM Service for Clients / Customers

 

 

 

 

Contact

Business Development
Please send us an Email!

 

 

Dr. Sylvie Bruchmann
Vice President

Dorothee Hoff
Director Clinical 
Trial Supplies

Dr. Dwight D. Stiff
Vice President 
Business Development

Dr. Florian Schwaak
Director 
Business Development