The Dutch drug development company that partners up with you and provides expertise that ranges from small molecules and re-purposed drug products to ATMPs and oligonucleotides. We help you in asking the right questions once you identify a lead candidate, lead your development programs toward approval, and provide you with the regulatory support to ensure your product stays on the market.
The Solutions We Deliver
Chemistry, Manufacturing & Control (CMC)
The manufacturing process, analytical testing, and product characteristics must be adequately defined and controlled to ensure a consistent, safe, and effective product. Working closely with our non-clinical, clinical and regulatory colleagues and broad network, we are able obtain reliable and comprehensive results which comply to GMP restrictions and the International Council on Harmonisation (ICH) guidelines.
We can support the whole range of non-clinical efficacy and safety studies, like (safety) pharmacology, toxicology, ADME and pharmacokinetics.
From the early pre-IND and pre-CTA stage of pharmaceutical development through to marketing applications, we can provide you with support in national and international dossier preparation, consultation, review, and filing.
Non-Clinical expertise to identify and solve potential gaps and give you the competitive advantage you need to get you to the clinic.
Clinical expertise to enable decisions based on evidence and ensure that your trials meet milestones and budget expectations.
CMC expertise that ranges from small molecules to oligos and allows you to work toward an efficient development program and a stable product.
Regulatory Affairs expertise in pre- and post-authorization regulatory activities to increase the chances of approval and continued compliance.
News & Content
At 3D-PharmXchange, we believe knowledge needs to be shared to develop clinical programs and to meet unmet patient needs. This is why we share publications, blogs, and other insights regularly. Feel free to leave us a message if you’d like more information on a specific topic.
Subscribe here and continue to learn from our experts by receiving our next updates.
"We can help companies better by being a smart, independent specialist in the service of drug development", that was, after solid careers at various Pharma companies concluded by Ronald van der Geest, Inez de Greef, and then Lars Bastiaanse, withdrew ten years ago....