Strategic Solutions

Strategy Review & Development

The single most important thing sponsors can do to ensure the success of their product is to have a sound regulatory strategy. Planning may seem straightforward, but most sponsors who attempt their first regulatory submission on their own do not succeed. It is easy to plan for the parts of the submissions you can see before you, but hard to plan for the unforeseen obstacles that will arise.

At Aleon strategic development is the first step in every new project. Our process is informed by hundreds of successful submissions, meetings and interactions with regulatory authorities around the world. Our team of experts covers every aspect of regulatory affairs with function teams covering Clinical & Regulatory Strategy, Clinical Pharmacology, Nonclinical, CMC, Regulatory & Medical Writing, eCTD Submissions, and Project Management. Working hand-in-hand sponsors our team comes together to develop the optimal strategy to bring your novel drug to market quickly and efficiently. If you are considering a submission in the next year, engage with Aleon and learn how to guarantee your product’s success!

Gap Analysis

As experts in regulatory affairs submissions, Aleon is constantly reviewing the status of programs to determine their readiness for milestone submissions such as INDs or NDA/BLAs. Contents of a Gap Analysis can vary greatly depending on the nature of the program, but typically they involve reviewing readiness for a milestone submission to regulatory authorities. In the case of INDs this usually means evaluation of nonclinical and CMC data based on Aleon’s knowledge and expertise, and a detailed report indicating the necessary steps to achieve a sponsor’s desired state before submission. Gap Analysis is often recommended before beginning Pre-IND or IND preparation, but each program is unique. Reach out today and our business development team will be happy to help determine if a Gap Analysis is right for you.

Due Diligence

Many companies in the pharmaceutical industry are ready to strike deals, but may not have the regulatory affairs expertise to complete an in-depth assessment of a business’ regulatory compliance before they proceed. Thai is where Aleon comes in. As experts in regulatory affairs we often act as the regulatory affairs team when sponsors need us. We can review the history of a company in question (search for FDA compliance concerns, evaluate current practices, etc.) and get you the information you need to make an informed decision. When in doubt, reach out!