Our Team

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).

 Services

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.

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 News

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  • A Strong Regulatory Strategic Development Plan
  • Preclinical Vendor Identification and Management
  • Pre-IND Development and Submission
  • Pre-IND FDA Conferencing
  • IND Development and Submission
  • Clinical Project Management
  • Ongoing Regulatory Support
  • ‚ÄčNDA Development and Submission
  • A Strong Regulatory Strategic Development Plan
  • 510(k) Development and Submission
  • IDE Development and Submission
  • Vendor Identification and Management
  • FDA Conferencing
  • Clinical Project Management
  • Ongoing Regulatory Support
  • PMA Development and Submission

Product Development for Emerging Technologies


If you already have a CRO, let Dr. Pekoe manage that relationship for you.

  • Biopharma or Device
  • Integral Team Member, not "Vendor"
  • Emotional Ownership of Your Project
  • IND Filings
  • 510(k)s
  • Strategic Regulatory Roadmaps

Link to Genetic Engineering New Article by Dr. Pekoe

"Regulatory Planning Key for Emerging Technology Companies"

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. 

NEW! FDA-Compliant Electronic Submissions

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.

Email:

gpekoe@arkios.com

Phone:

(757) 631-2114

Fax:

(859) 317-5990

Address:

632 Russell St. Covington, KY 41011



 Our device clients benefit from the following:

 We provide the following for our

  biopharma clients:

 REGULATORY PRODUCT DEVELOPMENT IS OUR SPECIALTY

We specialize in working with foreign companies seeking a US presence, and novel US emerging technologies.