Accelerate your drug development with Nuvisan's analytical services.
At Nuvisan, we provide more than just data; we enable the analytical clarity and confidence required for successful development. Our integrated analytical services span the entire drug lifecycle, from small molecules to complex biologics.
Our experts act as an extension of your team, providing proactive communication, flexible solutions, and invaluable insights to overcome challenging analytical hurdles.
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With our GMP and GLP-certified laboratories and more than 100 analytical experts across Europe, Nuvisan offers reliable and comprehensive analytical services.
Our labs are equipped with best-in-class equipment, with more than 3.000 m² GMP facilities available, including dedicated rooms to handle photosensitive, highly potent and controlled substances.
Nuvisan has decades of experience performing testing for small molecules and biologics like monoclonal antibodies (mAb), bispecific antibodies, ADCs and other recombinant proteins.
Our teams have the expertise to test raw materials, intermediates, active pharmaceutical ingredients together with finished products of different dosage forms: solid, semi-solid and liquid for innovative or generic products (human and veterinary).
We operate under GMP guidelines and are regularly inspected by authorities and customers with excellent track records giving you peace of mind for your regulatory filings.
Nuvisan provides comprehensive solutions across all development stages, from clinical phase 1 to phase 3, including commercial registration and post-market.
Leveraging data generated during the early stages, we implement and develop the appropriate set of analytical methods specifically adapted to the development stage of your product, enabling your success with:
Close communication, expert-led analytical support and flexible approaches help us deliver on-time projects that drive customer satisfaction.
Nuvisan’s European sites provide advantages for clients partnering with us to test products according to GMP and pharmacopeias.
Our analytical platforms scale to your needs, offering routine testing in ~10 days, with expedited options available. We support small molecule APIs, high potent APIs & biologics like monoclonal antibodies (mABs), antibody-drug conjugates (ADCs), bi/trispecific mABs and vaccines, as well as biosimilars and biogenerics.
With EU qualified persons (QPs) and certification as importer and manufacturer (MIA holder) for human, veterinary and investigational medicinal products, we act as a one-stop-shop partner. Our state-of-the-art equipment includes:
As part of the ALS group, Nuvisan also has direct access to technologies in ALS’ pharma labs around the world, enabling microbiological, elemental impurities, and extractable and leachable testing.
Nuvisan offers comprehensive stability programs to help ensure the quality and integrity of pharmaceutical substances and products throughout their lifecycle. Thanks to a large variety of parameters (including temperature, humidity and light), we can meet all regulatory and product-specific requirements.
In addition to regular long-term ICH stability programs, Nuvisan conducts short-term accelerated or forced-degradation studies, e.g., to support shelf-life determination.
With ~330 m³ of GMP-compliant storage, we have the capacity to meet your needs, helping ensure a smooth process and close communication at every step.
Impurities represent a frequent and often challenging task in development. Nuvisan can perform isolation, identification, synthesis and assessment of unknown impurities, including elemental impurities (ICH Q3D) and nitrosamines (ICH M7).
Our chemists and analysts join forces to solve most challenging issues encountered during a project’s development or lifecycle. We use a wide range of techniques to isolate impurities or synthesize them:
Nuvisan’s highly experienced scientists can help you select and control the solid state of your API.
We perform solid state investigations of small organic molecules to identify new solid forms such as polymorphs, salts, co-crystals or amorphous forms. These studies enable a deep understanding of the solid state of your intermediate or your API and include:
Nuvisan’s expertise is grounded in the pharmaceutical heritage of leading dermatology companies.
Developing successful topical drugs and dermatological products requires a nuanced analytical approach that goes beyond traditional oral or injectable forms. At Nuvisan, we understand the unique challenges of topical formulations – from helping ensure precise skin penetration and release profiles to optimising stability and sensory characteristics. Our deep expertise in dermatology and advanced in vitro testing according to international guidelines (eg FDA and EMA) allows us to provide specialised solutions for new product development or bioequivalence assessment (eg for generic products).
IVPT studies are crucial for assessing the rate and extent of drug permeation through the skin and other biological membranes. Establishing the characteristic permeation profile of a drug product using a discriminative IVPT in skin is of value in change control during life-cycle management and an acceptable permeation kinetic test to demonstrate therapeutic equivalence. With over 25 years of expertise in this field, Nuvisan is your ideal IVPT partner.
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IVRTs are critical for assessing the rate and extent of drug release from semi-solid topical dosage forms (eg creams, ointments, gels and lotions). They are used in pharmaceutical development for formulation optimisation, quality control and for supporting bioequivalence (BE) demonstrations of generic topical products. With more than 25 years of IVRT experience, Nuvisan offers strong expertise in understanding and following FDA and EMA guidelines.
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Rheology is a key factor in designing and producing effective topical products such as creams, gels, ointments and lotions. It can directly affect product performance, stability, manufacturing and user satisfaction. Nuvisan performs in-depth characterisation to ease product development or demonstrate equivalency for generics, including:
