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Pharmaceutical analytical services

In our three GMP- and GLP-certified laboratories with more than 100 analytical experts across Europe, Nuvisan offers comprehensive bioanalytical and CMC services throughout the entire product life cycle, from early research and development to manufacturing and commercialisation. Our laboratories undergo regular inspections and approvals by both the EMA and FDA. As an active member of the ICH guideline team, Nuvisan is dedicated to leading the way in industry standards and innovation.

Our labs are equipped with best-in-class equipment, with more than 5.000 m² GMP facilities including dedicated rooms to handle the most highly potent substances and products. Our teams have the experience and expertise to test active pharmaceutical ingredient (API) and finished products of different dosage forms (solid, semi-solid and liquid forms) as well as biosimilar and biological drugs.

Based on an analytical continuum, our testing experts provide solutions all along the value chain from early development to clinical trials. This includes method development, validation, quality control and stability studies of the main physicochemical and microbiological testing for innovative and generic products.

Nuvisan is committed to building strong and reliable partnerships with our global clients, spanning the pharmaceutical, biotechnology and veterinary industries, as well as research institutions. Our services are designed to help you bring safe and effective human and veterinary medicines to market.
Visualization of a biopharma company's workflow from lab to clinic, future of drug development

Method development and validation (DS/DP)

Building on a long-standing history of expertise in the development and validation of analytical methods, we have the internal capabilities to conduct method development, optimisation, qualification and validation for your in-house methods and products. Independently of the development stage of your products, we will implement the appropriate set of analytical methods.

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QC testing small molecules (DS/DP)

Nuvisan offers comprehensive services for quality control testing of small molecules (NCE, API, HPAPI, intermediates and raw materials). Once the drug specification is defined, together with our experienced team, our GMP-certified laboratories will ensure timely release of your drug substance or drug product batches in compliance with GMP practices and in accordance with ICH/VICH guidelines.  

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Testing of large molecules

QC testing of large molecules (DS/DP)

We do not only offer comprehensive services for the quality control (QC) testing of biologics like peptides and monoclonal antibodies (mABs), but our services also cover comparator studies for biosimilars and biogenerics, as well as analysis of antibody-drug-conjugates (ADCs) with highly potent conjugates. Nuvisan’s GMP-certified labs are equipped to support the testing needs of biologics, and our skilled teams conduct stringent analytical testing to meet regulatory standards. 

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Gate to refrigerated storage

Stability programs

At our GMP laboratories, we can provide superb support thanks to stability chambers with more than 320 m² of storage, and with a wide range of temperatures from -70°C to +60°C (zone I to zone IV). We also offer cycling studies, compatibility studies and photostability and transportation studies, as well as sample storage.

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Mechanical testing – material, CCIT and more

Nuvisan provides mechanical testing services to assess the integrity and performance of pharmaceutical packaging and delivery systems. This includes tests for seal strength, container closure integrity (CCI) and drug delivery device functionality. Using advanced equipment and GMP-compliant methods, we help ensure that packaging and devices meet regulatory standards and maintain product safety and efficacy throughout their lifecycle. 

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A lab technician wearing safety glasses and teal gloves uses an Anton Paar rheometer to analyze a sample

Semi-solid characterisation

Nuvisan offers expertise in semi-solid characterisation for the pharmaceutical and cosmetic industries. This includes assessing the physical properties of semi-solid formulations such as creams, gels and ointments, helping ensure they meet the necessary quality standards. Our comprehensive analytical services cover a range of tests for viscosity, rheology, texture, IVRT, IVPT and stability to optimise product development. 

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QP release

In addition to traditional pharmaceutical testing - encompassing chemical, physico-chemical and mechanical testing (small and large molecules), Nuvisan offers batch release overseen by an EU-qualified person (QP). The QP services include batch certification of commercial products for European market release.  

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