We are a specialty consulting group headed by Dr. Gary Pekoe, focused on small to medium sized biopharma and device companies the world over.
Dr. Pekoe and his team work with only a few select clients at a time, to assure them of the utmost attention and quality service.
When you trust your technology to Arkios, you can be assured we will take "emotional ownership" of your project and treat it as if it were our own. We become an integral part of your team, not a vendor.
From Strategic Planning to your Final Submission, we will help you be successful.
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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 17 years ago after experiencing that as Clinical Operations Director for a start-up company. Clients have described that same experience, 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:
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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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