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!



Exhibitions

CURIOUS 2018
Future Insight Conference
16.07. - 18.07.2018
Darmstadt / Germany


CPhI Korea
Mix the world of Pharma products, People & solutions
28.08. - 30.08.2018
Seoul / South Korea


BioFit
7th edition
Fostering Innovation & Transfer
04.12. - 05.12.2018
Lille / France