Synthon aims to become a recognized leader in specialty pharmaceuticals. The vertically-integrated model we have developed for small-molecule generics is expanding as we continuously strive to improve our R&D capabilities, global regulatory and IP expertise, and world-class manufacturing and supply chain operations.
We have extended this model to our new biological and new chemical entity technological platforms. Our innovative R&D and proven ability to manufacture and distribute high-quality pharmaceuticals position us well for our future in specialty pharmaceuticals.
Research and development remain vital to the overall value chain and are essential to our company. We therefore invest heavily in basic and applied research. In addition to chemical and (bio)pharmaceutical R&D, we carry out analytical and clinical research worldwide. We have our own fully-functional clinical drug development unit which is well-equipped to take our development phase compounds into clinical trials, up to and including Phase III.read more about R&D Generics read more about R&D Biopharmaceuticals
Our products are currently approved by regulatory agencies in around 100 countries worldwide and are marketed through strategic partnerships and - in dedicated areas - through direct sales. Our worldwide supply chain and manufacturing infrastructure meets the highest standards of quality and performance.read more about Synthon's sites and offices
We believe in a collaborative model, based upon strong partnerships with leading scientists, research institutions and partner companies. Our strategy of developing robust business-to-business partnerships enables us to share knowledge with and draw upon the specialist skills of partner companies. This helps to manage costs, deliver short product development cycle times and bring much-needed products to market. Such has been the success of our efforts that we now have over 200 partner companies today.business development Generics business development Biopharmaceuticals
Intellectual property rights will remain a crucial factor in the pharmaceutical industry. We actively promote and defend our interests worldwide, particularly with regard to patent and regulatory issues. To this end, we have access to high-quality legal representation and employ in-house patent attorneys, information specialists and support staff. By having the right legal expertise at hand, we can proactively ensure that our interests are fully protected and that a seamless and effective business operation is maintained.
We provide our customers with a complete product, including all components necessary for trouble-free registration, wherever in the world. In practical terms, this means that our experts are familiar - down to the smallest detail - with increasingly stringent and ever-changing regulatory regimes in more than 100 countries.
We compile registration files, compliant with the chemical, pharmaceutical and clinical requirements of regulatory authorities, such as the EMA, FDA and TGA. In cases where we out-license a biopharmaceutical before regulatory submission, our counterparts can count on detailed documentation and support that can eventually be used to build a dossier for submission.