Alava consultants have experience working for the top product developers, so we understand industry best practices and regulatory expectations. For antibodies and recombinant proteins using typical expression systems, we will develop a streamlined and low-risk CMC program to achieve your goals with the best possible speed and value. For biosimilars, we will help you navigate the connections between process and product characteristics, and develop a winning comparability strategy.
We also have a record of success in pioneering the technologies that will lead to the blockbuster products of tomorrow. Novel products and technologies require creative problem-solving and experience in overcoming CMC-regulatory challenges, while working with a narrower pool of suppliers.