REGULATORY PRODUCT DEVELOPMENT
OUR SPECIALTY
We are headed by Dr. Gary Pekoe, who has over 30 years experience developing products, including Augmentin, Bactroban, WinRho SD.
We specialize in working with foreign companies seeking a US presence, and novel US emerging technologies.
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Integral Team Member, not "Vendor"
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Emotional Ownership of Your Project
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IND Filings
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510(k)s
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Strategic Regulatory Roadmaps
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NEW! FDA-Compliant Electronic Submissions
The FDA will 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 compliant with the new FDA expectations.
From Strategic Planning to your Final Submission, we will help you be successful every step of the way.
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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 fees charged by large CROs 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.
Your technology is a priority
with Arkios.
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We provide the following for our biopharma clients:
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A Strong Regulatory Strategic Development Plan
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Preclinical Vendor Identification and Management
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Pre-IND Development and Submission
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Pre-IND FDA Conferencing
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IND Development and Submission
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Clinical Project Management
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Ongoing Regulatory Support
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NDA Development and Submission
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Our device clients benefit from the following:
A Strong Regulatory Strategic Development Plan
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510(k) Development and Submission
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IDE Development and Submission
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Vendor Identification and Management
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FDA Conferencing
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Clinical Project Management
- Ongoing Regulatory Support
- PMA Development and Submission
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