Guide Biomedical Solutions LLC
Guide Biomedical Solutions, LLC, also known as Guide-Bio, provides comprehensive tech advisory services for FDA-regulated manufacturers. The company is a proud member of key U.S. Government R&D and manufacturing consortia, offering wrap-around services from pursuit to post-market surveillance. Guide-Bio has a strong track record of helping clients secure significant non-dilutive funding and supports various biotech and life science organizations through strategic alliances and business development.
Industries
N/A
Nr. of Employees
small (1-50)
Guide Biomedical Solutions LLC
121 Valley Place, Media, PA 19063
Services
Advisory services covering product strategy, regulatory planning, design, validation and commercialization for FDA-regulated medical products.
Pursuit and proposal support for U.S. government funding programs, consortium participation, and grant capture.
Support for onshoring production, manufacturing scale-up, and coordination of multi-party manufacturing agreements to meet domestic content and government procurement requirements.
Design and implementation support for supply chain strategies, procurement, and cold chain distribution networks.
Portfolio governance, program management and project execution services for commercialization and government-funded programs.
Temporary executive leadership placements to provide operational and strategic guidance during transitions or early-stage scaling.
Advisory services covering product strategy, regulatory planning, design, validation and commercialization for FDA-regulated medical products.
Pursuit and proposal support for U.S. government funding programs, consortium participation, and grant capture.
Support for onshoring production, manufacturing scale-up, and coordination of multi-party manufacturing agreements to meet domestic content and government procurement requirements.
Design and implementation support for supply chain strategies, procurement, and cold chain distribution networks.
Portfolio governance, program management and project execution services for commercialization and government-funded programs.
Temporary executive leadership placements to provide operational and strategic guidance during transitions or early-stage scaling.
Expertise Areas
- Biomanufacturing and onshoring
- Supply chain development and cold chain logistics
- Regulatory strategy and USG program engagement
- Quality management systems and post-market surveillance
Key Technologies
- In vitro diagnostic (IVD) development
- Lateral flow / point-of-care antigen testing
- Biomanufacturing scale-up methods
- Cold chain logistics systems
News & Updates
Guide-Bio is an accepted member of the BARDA BioMaP and RRPV consortia, contributing to significant advancements in biotech and life sciences.
Since 2020, Guide-Bio has helped clients win over $85 million in combined non-dilutive funding from USG agencies.
Guide-Bio is an accepted member of the BARDA BioMaP and RRPV consortia, contributing to significant advancements in biotech and life sciences.
Since 2020, Guide-Bio has helped clients win over $85 million in combined non-dilutive funding from USG agencies.