Our FocusHG assists organizations involved in healthcare product-related research, development, and commercialization.
Working with both start-ups and well-established organizations, HG provides an independent source of professional, regulatory and technical expertise not generally available in-house or at a single institution. Due to the novel product areas we address, HG has unique capabilities of working across different regulatory categories - e.g., food AND drugs-- providing strategic guidance from leaders in the field. Due to the complexity of the regulatory systems, development projects generally require a multidisciplinary approach. This requires a team of individuals that can work together towards a common goal.
HG develops and directs teams based on the needs and scope of the project. Our experts come from a variety of disciplines: senior-level individuals with expertise from industry, academia and government who would not otherwise be available. Working together HG can address a broad range of product development scenarios. |
What We dO:HG provides advice and strategies to product sponsors, companies, investigators, Institutional Review Boards (IRBs), and other entities regarding the regulation of foods (dietary supplements, foods for special dietary uses, including Medical Foods), drugs, biologics, and medical devices.
Working closely with associates we also address intellectual property, business development, marketing and legal aspects of product development for the US and Canada. "virtual r&d"For many of our clients HG's serves in the capacity of a "virtual R&D" arm of their companies, bringing together experts from a broad range of scientific and regulatory disciplines:
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HeteroGeneity can address your questions on product development and help you define strategies for entry
into the US or Canadian marketplace.
into the US or Canadian marketplace.