Process development, analytical development, analysis, stability testing, manufacturing
Crystal structure by X-ray, solid form screening, solid form selection, IP support
Formulation development, analytical development, manufacturing, stability studies
Packaging, labeling, clinical trial logistics
Mass spectrometry, immunochemistry, flow cytometry, in-vitro drug discovery, clinical trial services
Scientific report writing, module 3 writing, regulatory CMC support
Guiding your nanomedicine candidate through its journey to the clinic
Developing and manufacturing formulations that lead to improved bioavailability
Meeting your needs from pre-clinical to small-scale commercial manufacturing
Bringing your oral drug to clinical trials quickly and reliably
Guiding you through the development of injectable drug products to GMP standards
Enhancing biomolecule purity with tailored solutions for GMP-grade materials at scale
Using the right standards at the right development phase, our comprehensive program management services streamline your small molecule drug development.
Helping you turn your compounds that show promise into GMP-grade drug substances.
We advance your clinical candidates through the pipeline quickly and safely with specialist drug product services.
Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.
Our comprehensive CMC regulatory services streamline preparation and submission of your registration file.
Using the right standards at the right development phase, our comprehensive program management services streamline your large molecule drug development.
We advance your large molecule candidates through the pipeline quickly and safely with specialist drug product services.
Our bioanalytical platform supports your large molecule drugs through preclinical and clinical stages with expert testing services.
Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your large molecule drug.
Using the right standards at the right development phase, our comprehensive program management services streamline your nanomedicine drug development.
We turn your nanomedicine candidates into suitable drugs with specialist development and manufacturing services.
Our bioanalytical platform supports your preclinical and clinical stages with expert testing services.
Our comprehensive CMC regulatory services streamline the preparation and submission of the regulatory files for your nanomedicines.
Agile and reliable, we guide you and your molecule through the complexities of drug development.
A legacy of scientific excellence, development expertise and integrated solutions.
Seven GMP/GLP facilities across Europe and the US, supporting innovation.
Guided by experienced industry leaders, our Board ensures strategic direction and excellence.
An international and diverse team of scientific and industry experts driving our progress and success.
A dynamic, passionate, and growing team with opportunities to learn and make an impact.
The chemical synthesis and supply of a drug substance is a time critical step in the process of defining and selecting a lead drug candidate for progress into a toxicology program and subsequently into first-in-human clinical trials. The presence of impurities can hinder toxicology results and delay entry into the clinic therefore it is important to identify and mitigate this risk. There are multiple potential causes of the formation or introduction of impurities regardless of the synthesis route used, including the materials used, the process conditions, potential cross-contamination, etc., and these can lead to several types of impurities.
The recent recalls of sartans and other medicinal products due to the presence of N‑nitrosamine impurities, increased the awareness of the impact of material selection, process changes, and cross-contamination, as well as the limitations of the existing analytical methods used. Many N‑nitrosamines are known to be carcinogenic to animals and are reasonably anticipated to be human carcinogens.
Please fill out the form to unlock the rest of the content.
Our team members share deep, scientific understanding and insights into their respective fields of expertise.
Sign up to receive drug development insights, the latest on industry trends & Ardena news.