Integrated dermatology solutions

Drug discovery capabilities

Our services are built around human-relevant models that offer insights at every stage of your research, from high-throughput screening of up to 150,000 compounds per day to detailed biochemical, biophysical and cellular assays. Our discovery teams deliver robust and reliable data, from ex vivo human skin explants for translational pharmacological testing to in vivo skin irritation and inflammation models for preclinical evaluation. Additionally, our in vitro assays enable detailed investigations into cellular behaviors such as migration, proliferation and skin repair. Whether testing single compounds or complex combinations, we accommodate a range of application procedures, enabling precise evaluation of your targets and substances.  
 
Our cross-functional team of DMPK and toxicology experts helps ensure seamless hit-to-lead conversion and lead optimisation by offering preclinical in vitro and in vivo tools for pharmacokinetics (PK) and toxicology evaluation, along with efficacy models for inflammatory and non-inflammatory skin diseases. In vitro permeation testing (IVPT) using human skin explants guides formulation and dosage choices early in the discovery phase. Our DMPK services provide comprehensive insights into the absorption, distribution, metabolism and excretion (ADME) of dermatological compounds. We assess tissue binding, penetration and stability with specialised in vitro models, while in vivo studies support PK profiling and effective dosing strategies. 

Our toxicology expertise helps ensure the safety and regulatory compliance of your products. We utilise a full suite of in vitro and in vivo models to assess dermal toxicity, irritation, sensitisation and phototoxicity in house or via a strategic partner. Advanced histopathological evaluations and biomarker analyses enhance the reliability of our safety data. Tailored studies address systemic exposure concerns, to help ensure your compounds meet the highest safety standards for regulatory submissions and risk assessments.  

Topical drug development – from drug substance to drug product 

Comprehensive dermatological drug development 
At Nuvisan, we provide end-to-end drug development solutions to transform your API into an effective topical therapeutic. Our expertise spans every stage, from initial concept to clinical trials, enabling a seamless transition from discovery to market. 

Chemical development and GMP manufacturing 
Our chemical development team specialises in route scouting and GMP-certified API manufacturing (1–10 kg) for toxicological and clinical studies. By closely collaborating with our formulation scientists, we optimise preformulation with advanced techniques such as XRPD, NMR, DSC, HPLC-UV and UPLC-UV, assessing polymorphism, solubility, compatibility and sensitivity. This integrated approach provides a robust foundation for the development of your drug product. 

Innovative topical formulation development 
We start with your target product profile (TPP) and in-depth preformulation data to design and screen multiple formulation concepts. Our approach includes: 

• Skin permeability testing: IVPT to evaluate effective delivery
• Stability and sensory analysis: comprehensive chemical, physical and microbiological stability assessments, as well as microstructure characterisation and sensory evaluation
• Local tolerance studies: helping ensure well-tolerated, effective formulas tailored to your compound’s specific needs. 
  

GMP manufacturing for clinical trials 
Once an optimal formula is identified, we produce GMP-quality topical drug products at a 10–50 kg scale, supporting regulatory toxicology and phase 1 and 2 clinical trials. Our clinical trial supply chain includes handling packaging, labelling and delivery to clinical sites, all fully compliant with EMEA/FDA standards. 

Early clinical trials and expert research facility 
Our state-of-the-art research hospital in Neu-Ulm, Germany, is equipped for early-phase clinical trials, including: 

• First-in-human (FIH) studies 
• PK and pharmacodynamic (PD) studies 
• Safety and tolerance evaluations. 

We have extensive experience managing complex studies, particularly for biologics, biosimilars and innovative drug modalities. 

Accelerate your dermatological drug development 
Our integrated dermatology solutions are designed to accelerate your drug development journey, helping you achieve proof-of-concept faster. Partner with us to bring your dermatological innovations to life.