Akesis provides experts to assist your company in mock regulatory audits, review of your quality systems including your CAPA plans, or any of the following services.
With the many recent advances in science and technology, and the increasing focus on safety, Regulatory Affairs plays a pivotal role in the global development of new therapies, products and devices. The Akesis Regulatory Team brings strategic experience to the NDA applications process and can successfully manage your application through FDA approval.
The New Drug Application (NDA) is the vehicle through which drug companies formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States. The purpose of an NDA is to provide enough information to permit the FDA to reach the following key decisions:
Once the NDA is approved, the drug product is assigned a six digit NDA tracking number by the FDA and the drug company may begin marketing the product in the United States.
Akesis has the expertise, experience and staff to facilitate getting your NDA tracking number.
Akesis is a 505(b)(2) NDA expert and is uniquely equipped to guide you through the application process. We deliver thorough feasibility assessments and a detailed strategy to serve as your project's roadmap. This systematic approach is driven by our team of scientific experts and highly qualified project managers.
What kind of application can be submitted as a 505(b)(2) application?
Akesis knows that being the first to file can make all the difference in profitability with generic drugs. We deliver a clear, expeditious program to help you be first to file. When you're ready to file, Akesis can prepare or support your team in the compilation of the electronic and paper ANDA. Our experienced staff is well versed on Office of Generic Drug procedures and FDA policies, and has intimate knowledge of all forms, documents, and submission requirements to guide our clients through the ANDA process. Akesis can also help you in performing your therapeutic equivalence trial for your generic drug.
The benefits of a successful 510(k) medical device application are typically a shorter timeline, minimal or no clinical testing, rapid FDA approval (under one year), and cost-efficiency. We have close professional relationships with the FDA and extensive knowledge of the submission requirements. We understand the nuances of the review process, eliminating the unknowns and dramatically increasing the probability of a successful review. Our goal is to get your device filed, approved, and on the market expeditiously.
At Akesis, we: