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Hack & Associates, LLC » Resources
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Designed and Developed by Paul R. Wind.
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Hack & Associates, LLC » FDA Regulatory Consulting
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Medical Device Packaging and Labeling. Hack and Associates provides consulting services and smart solutions to clients with logistical issues including packaging, labeling, product positioning, and lean manufacturing. We also focus on risk management and intellectual property valuation. Hack and Associates provides clients with assistance developing risk management portfolios by mapping out the intellectual property, regulatory, and reimbursement pathways for medical devices intended to come to market.
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Hack & Associates, LLC » Blog Archive » Welcome to H&A Consulting
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Welcome to H&A Consulting. Hack and Associates is a life sciences firm specializing in medical devices. We provide valuation and due diligence for intellectual property and FDA regulated devices. Hack and Associates provides clients with the following products:. Designed and Developed by Paul R. Wind.
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Hack & Associates, LLC » About H&A
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Hack and Associates is a life sciences consulting firm focused primarily on food and drug regulatory matters, intellectual property, corporate risk management, and asset valuation. We strive to provide our clients with the consulting services that best suit their needs. Hack and Associates focuses on issue spotting and formulating solutions that make the most business sense. H&A is committed to providing clients with complete solutions to unique matters. H&A also provides clients with the highest quality...
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Hack & Associates, LLC » FDA Premarket Services
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Investigational Device Exemption (IDE) Consulting. FDA Meeting Preparation & Attendance. Pre-market Approval (PMA) Consulting. Humanitarian Device Exemption (HDE) Consulting. 510(k), IDE, PMA, HDE Submission Drafting. Medical Device QSR Consulting. 510(k) Deficiency Letter Consulting. H&A also provides clients with a full range of pre-market and post-market services and strategies. We specialize in bringing products to market for which there are no clearly established regulatory pathways including:.
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