I founded Aleon in 2010 to provide high-quality regulatory services for innovative sponsors to move their drug and biologics programs forward. Our focus was simple: use our expertise to help companies of all sizes—particularly startups—better understand and accelerate novel drug development from IND all the way to NDA/BLA approval.
Since then, we’ve helped many sponsor companies achieve regulatory success in the development of small molecules, monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, cell & gene therapies and more with the FDA, NMPA, and EMA. Countless partners, many of which are now publicly traded on the NASDAQ, NYSE, SSE, and HKSE, have gained the approvals they needed to bring their novel drugs to market. We’re honored to have been a part of their journeys, and thrilled to see their innovations succeed.
Looking ahead, we’re focused on being the leading regulatory consulting company for new drug and biotech advances and continuing to help bring innovative treatments to market and patients in need. We’re committed to promoting and elevating the amazing work our partners do every single day.
Andrew Jiang & the Aleon team
Quality is our guiding principle. We strive every day to deliver superior work that’s worthy of the trust our clients have invested in us.
For us, good is never good enough. We go above and beyond to bring your innovative ideas to fruition.
We’re not just here to help. We’re part of your team. We communicate every day with sponsor companies to answer questions, provide guidance, and meet your most pressing business needs.
We’ve carefully cultivated and expertly trained our team. When you work with us, respect, courtesy, and professionalism are guaranteed.
The proof is in our work
Aleon has worked on more than 100 successful Investigational New Drug Applications, has completed a wide range of over 4,000 eCTD submissions to the FDA, and has extensive experience with New Drug Applications/ Biological License Applications (NDAs/BLAs).
Despite our successes, we know our firm doesn’t succeed unless our partners do. By working together, we help companies build strong relationships with regulatory authorities while, at the same time, leveraging our insights and expertise to clear the way for efficient regulatory approval.
Our competitive advantage? Our employees.
Our dedicated team is made up of passionate, creative, and experienced regulatory and industry professionals and former FDA staff members, scientists, and more. Their unparalleled expertise and commitment are what truly sets Aleon apart from the rest—why so many companies work with us to help them navigate the regulatory process.
If you’re interested in working together, get in touch and we’ll assemble a project team tailor-made for your program.
Get in touch