Valisure
Valisure is a pioneering technology company at the forefront of addressing a critical gap in the healthcare supply chain through independent quality assurance. Its mission is to revolutionize the broken supply chain by providing transparency to quality and independent certification through chemical analysis, aiming to improve drug safety, quality, and transparency across the healthcare industry.
Industries
Nr. of Employees
small (1-50)
Valisure
New Haven, Connecticut, United States, North America
Patents
Products
Batch-tested pharmacy model (previously operated)
A pharmacy workflow that dispensed only batch-tested medications validated by laboratory analysis; the operation was later divested to a pharmacy chain.
Batch-tested pharmacy model (previously operated)
A pharmacy workflow that dispensed only batch-tested medications validated by laboratory analysis; the operation was later divested to a pharmacy chain.
Services
Certification programs that verify product chemical composition and quality using laboratory testing and defined standards.
Advisory services covering vendor validation, selection of appropriate analyses, and resolution of testing discrepancies.
Market-level analytical surveys and studies to identify contamination or stability issues, supporting publications, reporting, and regulatory filings.
Rigorous evaluation of supplier and manufacturer quality through testing and documentation review to support procurement decisions.
Certification programs that verify product chemical composition and quality using laboratory testing and defined standards.
Advisory services covering vendor validation, selection of appropriate analyses, and resolution of testing discrepancies.
Market-level analytical surveys and studies to identify contamination or stability issues, supporting publications, reporting, and regulatory filings.
Rigorous evaluation of supplier and manufacturer quality through testing and documentation review to support procurement decisions.
Expertise Areas
- Independent quality assurance and product certification
- Analytical chemistry and contaminant detection
- Pharmaceutical supply chain assessment and vendor validation
- Regulatory advocacy and petitioning
Key Technologies
- Mass spectrometry
- Raman spectroscopy
- Selected-ion flow tube mass spectrometry (SIFT‑MS)
- Quantitative impurities analysis
News & Updates
Valisure & DoD Sign Agreement For Testing Drug Quality
Valisure has entered into a Cooperative Research and Development Agreement (CRADA) with the Department of Defense (DoD) in order to generate objective drug quality data through independent sourcing and chemical testing.
Valisure Tapped by White House to Address Drug Shortages and Quality Failures
Valisure has been recognized for its role in addressing drug shortages and quality issues, being invited to the White House for discussions.
U.S. Senate Testimony: Valisure on Drug Quality and FDA Oversight
Valisure’s leadership has testified before the U.S. Senate regarding drug quality and FDA oversight.
A Track Record of Action: Valisure’s FDA Citizen Petitions Driving Industry-Wide Change
Valisure has filed multiple FDA Citizen Petitions to address issues like benzene in products, leading to industry and regulatory changes.
A Bloomberg article highlighting Valisure’s efforts to improve drug quality and safety.
An NYT article discussing the issues in the drug supply chain and Valisure’s role in addressing them.
Valisure & DoD Sign Agreement For Testing Drug Quality
Valisure has entered into a Cooperative Research and Development Agreement (CRADA) with the Department of Defense (DoD) in order to generate objective drug quality data through independent sourcing and chemical testing.
Valisure Tapped by White House to Address Drug Shortages and Quality Failures
Valisure has been recognized for its role in addressing drug shortages and quality issues, being invited to the White House for discussions.
U.S. Senate Testimony: Valisure on Drug Quality and FDA Oversight
Valisure’s leadership has testified before the U.S. Senate regarding drug quality and FDA oversight.
A Track Record of Action: Valisure’s FDA Citizen Petitions Driving Industry-Wide Change
Valisure has filed multiple FDA Citizen Petitions to address issues like benzene in products, leading to industry and regulatory changes.
A Bloomberg article highlighting Valisure’s efforts to improve drug quality and safety.
An NYT article discussing the issues in the drug supply chain and Valisure’s role in addressing them.