Akkeri - [ /ˈãkːeri/ ] anchor, noun (Icelandic, from Old Norse)
We’re scientists, strategists, and your committed partners in the pursuit of advancing therapies to patients who need them. Anchored in science and driven by success, our team brings decades of expertise in diverse modalities including cell and gene therapy, oligonucleotides, protein-based biologics, and small molecule therapeutics. We strive to help you navigate the complexities of nonclinical drug development with a tailored approach. From initial program design through regulatory submission - we're with you to provide steady, reliable guidance at every step.
Nonclinical drug development isn't simply checking boxes.
Our approach is anchored in a deep understanding of the regulatory process and science-based strategy, enabling us to deliver creative, efficient pathways tailored to your unique therapeutic goals. Whether you represent a small biotech or a large pharmaceutical company, Akkeri maintains the flexibility to find the right pathway for you.
We begin by listening, to understand your therapeutic target, corporate goals, resources, and overall needs. Then, with a foundation of scientific expertise, we build a customized strategy to support your success from initial program design to regulatory submission. Our team includes industry experts and former FDA reviewers/supervisors, giving us a clear perspective on regulatory pathways, data interpretation, and risk management —elements that are vital to a successful drug development process.
At Akkeri, we know that every project—and every client—is unique. We take the time to understand your specific goals, whether you’re striving to develop new cancer treatments or pioneering therapies for rare diseases. This client-centered approach allows us to offer solutions that are as targeted as they are effective. Our team of former FDA and industry experts is here to support your mission with personalized guidance, creative approaches, and a dedication to excellence.
Our to You
Commitment
From early development through regulatory approval, we’re with you every step of the way.
We integrate with your team to align with your goals and work towards success
Comprehensive understanding of FDA and global regulatory pathways
Decades of experience in all aspects of nonclincal drug development