In-house eCTD system for all submissions
Aleon is very proud to have our own in-house eCTD submissions team with proprietary software that guarantees a successful submission of all documents. Our team has never had a document rejected, and often clients will seek us out for our outstanding eCTD service alone. Our team will format, compile, perform quality checks, publish, and submit all the necessary eCTDs to authorities on your behalf.
Client-Specific Regulatory Affairs Support
At Aleon our motto is, “Dedicated for Approval” and that is how we operate - the sponsor comes first. When we engage new sponsors for regulatory affairs support the first step we take is to gain a full understanding of the product at hand, and then to craft a regulatory approach that is right for your product and right for you as a company. We are 100% dedicated to making each product we work on a success and we believe that begins with a custom-tailored solution for each sponsor. Want to discover the optimal regulatory pathway for your product? Reach out today!
Safety Reports, DSURs, PSURs
Safety reports are an essential part of drug oversight and can require extensive communication with authorities as well as intimate knowledge of reporting requirements. Although some sponsors with large regulatory affairs teams can dedicate people to oversee these reports, most companies will find it easier to work with a consulting team who can manage all communications with authorities seamlessly.
GLP, GCP, GMP Compliance Audits
Good Laboratory, Clinical, and Manufacturing Practices are essential to quality drug development. They protect the hard work of the companies creating new treatments, and the wellbeing of the patients they serve. Aleon is proud to put our regulatory affairs knowledge to good use and assure that everyone is safe and protected. If you are curious about our GLP, GCP & GMP services, reach out to the business development team and they will gladly provide an in-depth introduction to our services.
Aleon Pharma International, Inc. is a one-stop, full-service regulatory affairs consulting firm. When you work with Aleon, we evaluate your program and carefully assemble a dedicated and experienced project team that is tailored to achieve your specific project goals. We have dedicated project teams in both the US and China who are specialized in Regulatory Strategy Development, Regulatory Writing, Chemistry, Manufacturing and Controls, Nonclinical Strategy, Clinical Development, eCTD Publishing, and submissions to the FDA, NMPA, EMA, and other regulatory agencies.
Aleon has worked with many sponsor companies over the years, and our team has developed streamlined processes that enable us to effectively provide high-quality services that help you achieve approval for your innovative drug candidates.