Valisure

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Valisure


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Lab Biography

INDEPENDENT ANALYSIS

In most consumer markets, independent measures of quality are available to help differentiate brands and offer independent quality assurance to purchasers. However, in pharmaceutical and consumer healthcare products, this largely doesnโ€™t exist, and thatโ€™s what Valisure is working to change.

Regulators, like the FDA, consistently inspect facilities and require that manufacturers perform routine testing of their products according to Good Manufacturing Practices (“GMP”). However, very rarely are products sampled and tested by regulatory agencies. GMP testing is very brand-specific, often leading to dozens of methods for a single type of product, but independent testing follows scientific principles that apply broadly and can screen many different products with a single method.

Valisureโ€™s independent testing, accredited to International Organization for Standardization (โ€œISO/IEC 17025:2017โ€) standards, has been uniquely developed to effectively screen through thousands of products and has already made a global impact.

Qualifications

PERRY JOHNSON LABORATORY ACCREDITATION, INC.
Certificate of Accreditation
Perry Johnson Laboratory Accreditation, Inc. has assessed the Organization of:
Valisure, LLC
285 Nicoll Street, Suite 106, New Haven, CT 06511
and hereby declares that the Organization is accredited in accordance with the recognized International Standard:
ISO/IEC 17025:2017
Whereby, technical competence has been confirmed for the associated scope supplement, in the fields of:
Chemical Testing (As detailed in the supplement) Accreditation claims for conformity assessment activities shall only be made from the addresses referenced within this certificate and shall apply solely to those activities identified in the related scope. This Accreditation is granted subject to the Accreditation Body rules governing the Accreditation referred to above, and the Organization hereby commits to observing and complying with
those rules in their entirety.
Initial Accreditation Date: Issue Date: Expiration Date:
January 25, 2017 May 16, 2025 August 31, 2027
Accreditation No.: Certificate No.:
94238 L25-391
The validity of this certificate is maintained through ongoing assessments based on a continuous accreditation cycle. The validity of this certificate should be confirmed through the PJLA website: http://www.pjlabs.com
For PJLA:
Tracy Szerszen
President
Perry Johnson Laboratory
Accreditation, Inc. (PJLA)
755 W. Big Beaver, Suite 1325
Troy, Michigan 48084

Certificate of Accreditation: Supplement
Valisure, LLC
285 Nicoll Street, Suite 106, New Haven, CT 06511
Contact Name: Tara Svendsen Phone: (475) 201-9088
Accreditation is granted to the facility to perform the following conformity assessment activities:
Issue:05/2025 This supplement is in conjunction with certificate #L25-391 Page 2 of 3
FIELD OF TEST ITEMS, MATERIALS, OR PRODUCTS TESTED COMPONENT, CHARACTERISTIC, PARAMETER TESTED SPECIFICATION OR STANDARD METHOD TECHNOLOGY OR TECHNIQUE USED FLEX CODE LOCATION OF ACTIVITY
Chemical Medicinal Products, Cosmetic Products, and Dietary Supplements (Solids, Liquids, and Aerosols)
Dosage Test Internal SOPPR-
002, PR-019
Raman
Spectroscopy
F1, F3, F4 F
Chemical Medicinal Products, Cosmetic
Products, and Dietary Supplements
(Solids, Liquids, and Aerosols)
Excipient Identification Internal SOPPR-
002, PR-019, PR-023
Raman
Spectroscopy
F1, F3, F4 F
Chemical Medicinal Products, Cosmetic
Products, and Dietary Supplements
(Solids, Liquids, and Aerosols)
Dissolution Test USP <711> Dissolution
Internal SOP- PR-014
Dissolution
Apparatus
F1, F2, F3, F4 F
Chemical Medicinal Products, Cosmetic
Products, and Dietary Supplements
(Solids, Liquids, and Aerosols)
Gluten Detection Internal SOP- PR-022 LC-HRMS F1, F3, F4 F
Chemical Medicinal Products, Cosmetic
Products, and Dietary Supplements
(Solids, Liquids, and Aerosols)
Elemental Impurities Test USP <233> Elemental
Impurities
Internal SOP- PR-021
ICP-MS F1, F2, F3 F
Chemical Medicinal Products, Cosmetic
Products, and Dietary Supplements
(Solids, Liquids, and Aerosols)
Dosage Test Internal SOP – PR-017 HPLC F1, F2, F3 F
Chemical Medicinal Products, Cosmetic
Products, and Dietary Supplements
(Solids, Liquids, and Aerosols)
Impurities Test: Nitrosamines,
Residual solvents, and other
Organic Impurities
FDA FY19-107-DPA-S
5/21/2019
Internal SOP-PR-020
LC-HRMS F1, F2, F3 F
Chemical Medicinal Products, Cosmetic
Products, and Dietary Supplements
(Solids, Liquids, and Aerosols)
Impurities Test: Nitrosamines,
Benzene, Residual Solvents,
and other Organic Impurities
FDA FY19-005-DPA-S
USP <467>
Internal SOP-PR-018, PR-033
GC-MS F1, F2, F3 F
Chemical Medicinal Products, Cosmetic
Products, and Dietary Supplements
(Solids, Liquids, and Aerosols)
Broad Analyte Identification of
Active Ingredients, Inactive
Ingredients, and Impurities
Internal SOP-PR-030 LC-HRMS F1, F3, F4 F
Chemical Medicinal Products, Cosmetic
Products, and Dietary Supplements
(Solids, Liquids, and Aerosols)
Benzene Gas Internal SOP-PR-029 Selected Ion Flow
Tube โ€“ Mass
Spectrometry
F1, F3, F4 F

Standards & Methodologies

ISO/IEC 17025:2017

Industry Types Served

  • Agriculture & Agribusiness
  • Biotechnology & Life Science Products
  • Consumer Goods & Retail Products
  • Cosmetics & Personal Care Products
  • Food & Beverage Products
  • Pharmaceuticals & Biopharmaceuticals

Lab Testing Types Offered

  • Bioassays & Functional Testing
  • Chromatography & Spectroscopy
  • Contaminants & Pollutant Testing
  • Food & Ingredient Quality Testing
  • Metals & Alloys Evaluation
  • Microbiology & Pathogen Detection
  • Mycotoxins & Contaminants Testing
  • Performance & Durability Evaluations

Location

New Haven, United States

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