Pharmaceutical

PHARMACEUTICAL
ANALYTICAL SERVICES

Among 3 GMP sites in Europe, wide range portfolio of analytical devices, expertise and infrastructure in place to provide solutions on the highest level of quality with 40 years of experience

Method Development, Validation and Transfer

ICH/VICH/ ANVISA compliant, Forced Degradation Studies

Microbiology with Preservative Efficacy and Microbial Limit Tests Tests (USP & Eur Ph)

Container Closure Integrity Testing by Blue dye ingression, High Voltage Leakage Detection and Laser Headspace Oxygen

APIs, Raw Materials, Oral dosage forms with small Molecules, Semi-solid dosage forms, liquid dosage forms,

Peptides, Hormones, Proteins and Polymers, Transdermal delivery systems

Capacities

3000 m² GMP laboratory space incl. >320 m² stability storage capacities (from -70°C to +60°C)

State of the Art Laboratory Platform

28 HPLC, 8 UPLC and 4 GC, 1 GC/FID, 1 GC/MS, 5 LC/MS, 1 XRPD,…

80 very experienced Analysts

LIMS

Highlights

Certified by local and international authorities (Germany, France, US FDA, GLP Tox 9, ICH)

Human and Veterinary medical Products

Handling of highly potent API up to HHB5, controlled drugs, and narcotics

Microstructure Characterization

Investigations and Troubleshooting Support

Environmental testing (air, water, surfaces)

Quality Control

EU-Release testing

ICH Stability Studies Zone I to IV (incl. Cycling-Compatibility-Photostability-Transportation Studies) and sample storage

Packaging Safety and Performance

Cleaning Validation

QP Services

WHY WORKING WITH NUVISAN?

Start in 1983 as internal QC-Unit (Formulation & Phase I), 1996 Opening for external Contract Services

EXPERIENCE & KNOW-HOW:

> 200 Projects conducted per year in average

CUSTOMER SATISFACTION:

> 90% Repeat Business

EXPERTISE:

State of the Art Equipment and Technologies: Chromatography Testing, NMR

Site Sophia Antipolis: Former GALDERMA Analytical Development and Quality Control Department

OUR CLIENTS IN THIS SECTION

Partner for Biotech, Start-up, Mid-size & Big Pharma Companies

Pharmaceutical and Cosmetic Industry, API Manufacturers, Veterinary companies for integrated & Stand-alone Projects

Any stage of development : from Research, through the clinical phases and for commercial purposes

Summary

Neu-Ulm

Center of Excellence in Oral Drug Testing

Experience on project in development and commercial worldwide

US FDA Inspection done in July 2014 in Addition to GMP

Large capacities to handle ICH stability programs in house

 

Waltrop

Center of Excellence in Biological Testing

Unique capacity to Test Container Closure Integrity via High Voltage Leakage Detection and Laser Headspace Oxygen

US FDA Inspection done in 2016 in addition to GMP

Large capacities to handle ICH stability programs in house

 

Sophia Antipolis

Strong expertise in Method Development

GMP Certification renewed in 2020

Drug Substances, Preclinical and Clinical Batches testing