SITE WALTROP

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Partner for Pharmaceutical Industry

Pharmaceutical Services with focus on cGMP compliant release and stability testing of pharmaceuticals. We offer method development, transfer and validation of methods for a wide range of APIs and formulations ranging from small molecule tablet formulations to parenteral therapeutical antibody solutions.

Our Pharmaceutical Services site in Waltrop is also our excellence center for physical testing of primary packaging, specialized on Container Closure integrity testing (blue dye, Headspace analysis, High Voltage Leakage detection) and Break-loose/Glide-force testing.

Infrastructure

Headcount: 34 employees (25% university graduates)
Laboratories: 1200 m²
Storage Capacity: 400 m³


Inspections & Authorizations

GMP certified and manufacturing license (2004) for human and veterinary products
FDA inspected (2016)

History

From Big Pharma to Family Business

Established in 1982 by Thiemann Arzneimittel GmbH, the analytical department in Waltrop benefited from acquisitions by Big Pharma companies:

  • acquired by Organon in 2000
  • acquired by Schering-Plough in 2007
  • acquired by Merck, Sharpe & Dohme in 2009

Since 2011 the site in Waltrop is part of the NUVISAN group and is one of the key laboratories for GMP services located it Germany (Neu-Ulm/Waltrop) and France (Sophia Antipolis).

 

Working Fields and Specialties

Pharmaceutical Analysis of small and large (bio) molecules.

Focus on UPLC/HPLC (UV, CAD, FLD), GC, LC-MS, ELISA, Dissolution, Karl-Fisher, BL/GF, CCIT (FMS, HVLD) and more.

Method development, transfer and validation in compliance with ICH guidelines (cGMP).

Stability storage (walk-in climate chambers, climate cabinets, fridges, freezers) from -80°C to +40°C.

Experiences with various formulations (tablets, capsules, powders, implants, transdermal delivery systems, liquids).

Dedicated project management to develop customer tailored solutions and timely provision of deliverables (protocols, reports, CoAs).

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Our Services & Solutions along
the Drug Development Value Chain

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Discovery

PRECLINICAL

Clinical Phase I

Clinical Phase II

Overall Services

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management

NUVISAN Overall Services along the Value Chain

API Manufacturig
(Non-GMP / GMP)

Formulation
Development

Pharmaceutical
Analysis

Bioanalysis
(Discovery and Regulated)

Biomarkers
(exploratory & GxP)

Translational
Pharmacology

Healthy Volunteers
& Patient Studies

Clinical Trial
Supplies

Regulatory
Affairs

Backend
Services

Corporate Project
Management