Small molecule therapeutic agents typically refer to types of medication or drug that consists of relatively small-sized chemically derived molecules. Development and registration of these therapeutic agents typically involve specifics that vary depending on the phase of development, country or region where the registration is sought, and type of product.
Our small molecules team has supported numerous companies, ranging from the set-up for development and preclinical studies, via clinical trial applications, to marketing authorization applications and post marketing variations. Furthermore, we have assisted our clients with, among others, preparation of briefing packages for (and including) scientific advice meetings, due-diligence and/or gap assessments, project management, and acted as project or team lead in internal teams.
We focus on meeting your goals and due dates by an efficient execution of the projects, find the optimal solution for issues at hand, all in line with current guidelines and regulations.
Being qualified as an SME in the EU, we are also able to transfer such benefits to our SME clients, e.g. reduced fees, less administration and easy access to the (regulatory) support from Health Authorities, such as EMA.
If you are developing and/or want to register small molecules as therapeutic agents, and in need for any kind of support, please do not hesitate to contact us via Contact form.