Regulatory Consulting - Kinetiq
On-Demand Consulting to Accelerate Your Clinical Trial
Our trained regulatory attorneys and compliance professionals provide actionable, effective solutions to complicated research scenarios and product development. Plus, we track and address the ever-changing legal and regulatory landscape to provide current, on-demand regulatory support tailored directly to you.
Get your on-demand regulatory support today.
Drugs and Biologics
From the latest immunotherapies and gene therapy products to new indications for small molecules, Kinetiq helps overcome hurdles to enable research on drugs, biologics, and other products regulated by government agencies in the United States and abroad.
In the often challenging and confusing medical device research environment, Kinetiq delivers expert guidance in international regulatory standards for medical device development and research. We specialize in research involving in vitro diagnostic products, combination products, wearables, and medical device related cyber technology issues.
With medical information increasingly delivered and collected via social media, mobile devices, and cloud- and software-based platforms, Kinetiq is here to support your digital health innovations in wearable devices, precision medicine, mobile health (mHealth) apps, Part 11, HIPAA, and HITECH compliance.
Whether your vision involves establishing and maintaining a traditional repository, facilitating identification and transfer of on-demand specimens with associated health or genetic information, or beyond, our regulatory experts offer efficient solutions to potential ethical and practical implementation hurdles to move your research forward.
Good Clinical Practice (GCP)
Understanding clinical research requirements is crucial to remaining compliant and effectively conducting research. Kinetiq supports U.S., Canadian, and global client research endeavors through GCP auditing, training, and—where necessary—responding to an FDA Form 483 to prevent warning letters or further regulatory action.
Whether a sponsor, CRO, hospital system, academic medical center, IT company, or independent researcher, Kinetiq moves your research forward.
Read more about Kinetiq Regulatory Consulting offerings.
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Contact Kinetiq today to schedule a needs analysis.Contact Us