Ardena is a contract partner delivering pre-clinical and clinical drug development, manufacturing and bio-analysis services to clients internationally. Quite simply, we’re a CDMO that guides companies through the drug discovery and development process to help create effective and compliant drug products for clinical trials. Headquartered in Ghent, we have facilities in the Netherlands, Belgium, Sweden and Latvia, serving a global customer base, ranging from emerging biotech to tier-one pharmaceutical companies.
We have an extensive track record in executing solid state research studies, which are designed to help you explore the true potential of your molecule.
Through a combination of high- and medium-throughput screening services, state-of-the-art analytical techniques and experimental work at different scales, we can help you to obtain a complete range of solid forms of a drug substance.
We are also able to handle highly potent and controlled substances.
Our areas of expertise include crystal structure by X-ray, crystallisation process support, IP support, single crystal growth, solid form screening and solid form selection.
Pre-formulation, or the physicochemical characterisation of your API in light of the intended route of administration and dosage form, is an important phase in your development program.
We can help you to select the appropriate solid form based on a number of criteria such as chemical and physical stability, dissolution and solubility in relevant biological media. Our focus is to maximise the probability of the API’s success in preclinical studies, helping you to establish strong intellectual property positions.
Navigating the preclinical toxicology phase for any new molecule is no easy task. At this phase, 50% of the candidates fail for toxicity reasons and another 15% fail for lack of bioavailability and short half-life. It is our job to use our pre-formulation development expertise to give your molecule the best chance of success.
Our extensive package of pre-formulation services support your development programs from early candidate selection, through preclinical, and into the clinic.
At Ardena, we guide our customers into making smarter formulation choices. Ultimately, this reduces the risk of clinical failure and ensures your product reaches the clinic rapidly using the most efficient route.
Solving a problem and saving time
Overcoming formulation development challenges is our specialty. We work closely with our customers to understand their formulation needs and develop the best possible formula.
We have the capabilities to develop formulations for a very broad range of administration routes, including oral, topical, intranasal, ocular and intravenous.
We’ve navigated your drug development challenges and found a formulation that works. Now it’s time to take your project seamlessly to the clinical supply manufacturing stage.
On time delivery is fundamental when it comes to manufacturing clinical supply. For all of our customers, missing the clinical study start date is not an option. That’s why you can trust us with your timescales.
Through our clinical supply manufacturing services, we play a critical role in helping you to meet your deadline and ultimately achieve your clinical milestones.
Pharmaceutical dossier preparation services form an important part of our role in navigating customers through drug development.
Our dossier-centric approach to projects means our customers stay ahead of the game when it comes to advancing products to clinic.
From data review and reporting to regulatory dossier writing and submission, we can help. Our track record speaks for itself…
500 marketing authorisation dossiers, including variations and extensions
300 clinical trial applications (IMPDs, INDs)
50 certificates of suitability (CEPs)
10 long-term customer projects related to implementation of new legislation and compliance
100 drug product development reports
100 API development reports
We work with you to compile your regulatory dossier in parallel with drug development, saving you time, identifying hurdles and fast tracking your product towards compliance.
Our expertise covers:
Smart, dossier-centric development. That’s what we’re about.
Our years of drug development experience have taught us that challenges are just a part of what we do. Our experienced team of scientists thrive on helping you to overcome hurdles throughout the drug development process. Let us help you to progress your promising molecule to clinic.
And as an added benefit, by developing your dossier in parallel with drug development, we can save you time and fast track your product towards compliance.
"Yes, we would work with Ardena again as we have been satisfied with their services."
Ardena has not received any endorsements.