Lead Consultant and Founder - Dr. Gary Pekoe, PhD. Dr. Pekoe has over 30 years experience in successful product development. He managed the clinical development of the only single-agent topical antibiotic approved by the FDA, Bactroban (mupirocin) for Beecham (GSK).
Your technology is a priority at Arkios.
Arkios is able to step in at any point in your development program to provide you with comprehensive project management services. We are cost-effective and have a rapid response time designed to accelerate your development process.
From strategic planning to your Final Submissions, we will help you be successful every step of the way.
Arkios has never had a project discontinued due to performance.
Customer satisfaction is our number one concern. If we do not believe your project is a good fit for us, we will tell you.
If you already have a CRO, let Dr. Pekoe manage that relationship for you.
As a small company, you cannot afford to pay the high charged by large CRO's with their huge personnel burdens, nor can you afford to be in line behind larger clients. I started Arkios 20 years ago after experiencing that very situation as Clinical Operations Director for a start-up company. Our clients have described similar experiences, and their desire for their technology to be a priority in the hands of their provider.
The FDAwill soon be requiring all company submissions to follow the electronic CTD guidelines. Arkios will be the cost-effective solution for small companies needing to be complaint with the new FDA expectations.
632 Russell St. Covington, KY 41011
Our device clients benefit from the following:
We provide the following for our
REGULATORY PRODUCT DEVELOPMENT IS OUR SPECIALTY
We specialize in working with foreign companies seeking a US presence, and novel US emerging technologies.