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)
CMC is a fundamental part of the drug development process and incorporating CMC early in the process ensures that stringent product requirements from competent authorities are met and is critical to project success.
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.
Whether you need expert guidance to design your non-clinical program from the moment of selection of your most promising development candidate, or whether you need experienced insight to conduct a gap analysis for an existing program, the non-clinical consultants at 3D-PharmXchange have the proven knowledge and are capable to provide the necessary support you need.
We can support the whole range of non-clinical efficacy and safety studies, like (safety) pharmacology, toxicology, ADME and pharmacokinetics.
We aim to develop and effectuate complete clinical research projects, focusing on clinical pharmacology and providing you with translational insight. Our track record shows our ability to deliver excellent study designs, protocols and reports, and our capability to function as dedicated liaisons for our clients. With access to the latest technologies, we combine our flexibility, experience, and strong teamwork to provide you with the best solutions.
The practical and skilled approach of our RA team ensures a comprehensive strategy for pharmaceutical product submission and approval by regulatory authorities. With decades of experience under our belt, we can anticipate oncoming issues and offer integrated expertise to your advantage.
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.
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.