Aleon Pharma
International
Milestone Submissions
IND Preparation & Submission | IND Amendments | Annual Report/DSUR
Looking to get your drug approved for clinical trials? An Investigational New Drug application (or IND) is required in most major markets, including the US, China & Europe (CTA). Aleon Pharma International, Inc. specializes in the preparation and submission of INDs to the major markets. Our team has a 100% success rate on over 100 INDs without ever asking a client to delay their schedule. Whether you are looking to submit a new IND or maintain an approved IND, Aleon’s team of former FDA reviewers and industry experts will not only provide the expertise needed to assure you have the right regulatory approach, but will also draft, review and submit your IND. Make us your IND consultant today, and we will make your product a success!
The Aleon IND process starts with a careful review of your program via our custom IND questionnaire, and our proposals are specifically tailored to the needs of each of our clients. This can include:
- Gap Analysis
- Pre-IND Meeting Preparation and Submission
- IND Preparation & Submission
- Aleon can prepare all modules 1-5 (recommended) or provide review
- eCTD Preparation & Submission
- Clinical & Synopsis Protocol Design or Review
- Acting as the US agent
- Annual IND maintenance
NDA/BLA Preparation & Submission | NDA/BLA Amendment | Annual Report
Is your drug ready to go to market? A New Drug Application (NDA) or a Biologics License Application (BLA) is required in most major markets, including the US, China & Europe (MAA). Aleon Pharma International, Inc. has rich experience with the preparation and submission of NDAs & BLAs to the major markets. To date Aleon has helped bring 10 new drugs to the global market with several more in development. An NDA is the culmination of many years of research and development and significant financial investment - ensure the success of your product by working with the team at Aleon!
The Aleon NDA/BLA process starts with a careful review of your program via our custom INDA/BLA questionnaire, and our proposals are specifically tailored to the needs of each of our clients. This can include:
- Gap Analysis
- Pre-NDA/BLA Meeting Preparation and Submission
- NDA/BLA Preparation & Submission
- eCTD Preparation & Submission
- Acting as the US agent
- Annual Report
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.