Comprehensive Regulatory Support for All Phases of Development
With highly experienced regulatory experts in the United States, Europe, and China, we are an extension of your regulatory team. Let us streamline your product development with cutting-edge regulatory strategies, author your important regulatory documents, and manage interactions with regulators for a smooth development process.
Meet Success With a Dedicated Project Manager and Knowledgeable Experts
Every program at Amador is supervised by a dedicated translational project manager. When you meet with our team, you meet directly with our experts to make decisions, solve problems, and align cross-functionally. We keep deliverables and timelines on task for a successful IND submission and preparation to enter the clinic.
Our goal is to establish a clear channel of communication with regulatory reviewers aiming to ensure that the investigational product pathway plan correctly anticipates what the regulatory authorities will require for optimal product development.
We can help with products that fall in the following categories: small molecules, ADCs, biologics, biosimilars, radiopharmaceuticals, 505(b)(2) applications, cell and gene therapy products.