Who we are
We are a full-service consulting company that understands that strategy is key for clearance and
approval of drugs, medical devices, and combination products. With a go to market focus, we use
our rigorous scientific backgrounds to provide regulatory support to help clients develop their
research and clinical products to achieve their business goals.
Our services
Biomedical Research Product and Process Development
First Edge can also help your company develop and optimize your biomedical research products and platforms. We bring over 20 years of expertise in managing research and development (R & D) projects to support new product development and manufacturing.
Intellectual Property
We have extensive experience in the creation of intellectual property (IP) and patent preparation for biomedical products and drugs and understand that capturing IP is key for most companies.
Clinical Product and Process Development
We have designed and developed several clinical products in R & D laboratories and contract research organizations (CROs). We also have worked with CROs in the design and execution of pre-clinical safety and efficacy studies to include in regulatory submissions.
Regulatory and Clinical Trial Management
First Edge has a long track record of productive and successful interactions with regulatory agencies. We provide comprehensive guidance to our clients so that the necessary submission packages include what is needed for clearance or approval.
Quality management Systems
We understand the importance of a well-constructed and managed QMS and can assist clients in the construction and maintenance of your system.
Manufacturing
First Edge can facilitate the optimization of your research and GMP clinical products by building productive relationships with experienced manufacturing contractors and partners.
contact us
Send a message via the form, or reach out directly.
© 2023 First Edge Consulting, LLC. All rights reserved.
info@firstedgeconsulting.com