Health and Regulatory Affairs
Gehrke & Associates, SC offers legal and bioethical assistance for healthcare and healthcare related industries. If you are a healthcare or healthcare related organization with a research and development program, verifying compliance with current CFR research standards, including compliance with human research subject guidelines, can be a real distraction from the work you want to do. We offer reviews of your policies to determine compliance with current legal and ethical demands. While the clients who use this service typically are involved in pharmacological, biologic, and medical device research and development, any research activities involving human subjects or human derived materials should be concerned with compliance with CFR regulations.
Gehrke & Associates, SC integrates its intellectual property expertise into it health and regulatory affairs practice allowing a better understanding of your whole R&D program. We can assist in creating a patent and FDA strategy that will protect your investment and maximize your time on the market.
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