About Us
Why Graywolf Research
Experience the Difference
Why Graywolf Research
Our professionals have a combined 130 years of clinical research/design and medical writing experience in all aspects of regulatory affairs for medical devices and pharmaceuticals.
How We Help
Experience the Difference
Why Graywolf Research
We partner with the FDA, EU Notified Bodies and the regulatory bodies within the IMDRF to ensure that your medical devices meets/exceeds all regulatory requirements for market access.
Experience the Difference
Experience the Difference
Experience the Difference
Our researchers, regulatory experts and medical writers are all industry leaders that bring a wealth of knowledge and experience to your project.
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Our Services
Clinical Trial Management
From establishing clinical trial protocols through conducting your clinical trial, our experts provide the very best scientific knowledge in the industry.
Regulatory Affairs
Our team of experts analyzes, creates and submits your regulatory documents for approval to world wide regulatory bodies.
We provide regulatory audit preparation and support for/during remote or at desk audits.
We provide assistance in creating work instructions and help generate standard operating protocols.
Medical Writing
Our scientific experts provide professional writing services for:
FDA 510(k) Submissions
EU MDR Submissions
Australian TGA Submissions
Brazil ANVISA Submissions
Health Canada Submissions
Japan PMDA Submissions
Singapore Health Sciences Authority Submissions
Reviews
Contact Us
Please call or email us today to schedule a free consultation.
Feel free to call us at: 1-513-445-3575
The Graywolf Research Group
201 East Fifth Street, Cincinnati, Ohio 45202, United States
Direct: 513-445-3575 Email: David@graywolfresearchgroup.com
Hours
Monday - Friday: 9:00am - 5:00pm
Saturday - Sunday: Closed
Copyright © 2022 Graywolf Research Group - All Rights Reserved.
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