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CONSULTING SERVICES

Official MethodsSM Program (OMA) Validation Testing Protocols and Plans

AOAC CONSULTING SERVICES

AOAC INTERNATIONAL is announcing an expansion of accessibility to the AOAC Consulting Service for all method authors intending to submit methods to the Official MethodsSM (OMA) program.

The Consulting Service originated within the AOAC Research Institute as an OPTIONAL service designed to develop and provide complete individualized approved validation outlines for method developers aspiring to submit their methods to AOAC Performance Tested MethodsSM (PTM) program. The newly expanded AOAC Consulting Services include:

  • Validation Testing Protocols and Plans

    AOAC Consulting Services for Validation Testing Protocols and Plans develops validation testing outlines for sole source and proprietary submissions and/or submissions in response to an active call for methods that will include all pertinent testing protocols, acceptance criteria, and information on reference materials or reference methods, and more.
  • Joint Program Protocol Development

    Joint program protocol development or harmonized validation outlines can be developed to satisfy requirements of both programs. Additionally, a validation outline for a method to be submitted for PTM review can be designed and reviewed to satisfy the requirements for methods in the OMA program. 

BENEFITS

  • This optional service leverages the expertise and experience of AOAC consultants, AOAC Expert Review Panels along with global subject matter experts to develop, peer review, and approve testing protocols for AOAC.
  • Consulting service allows method developers to quickly organize your study to collect the exact data needed to evaluate and validate a method.
  • Reduces and eliminates the guesswork and risk of potentially expensive re-testing.
  • Approved AOAC validation testing protocol for the Official MethodsSM program will allow method authors and study champions to quickly organize method studies to collect the exact data needed to evaluate and validate a method.*

    *Use of the service does not guarantee or infer a method approval.

APPLY FOR CONSULTING SERVICES

Step 1: Application Process

Method Author or Champion Submits Consulting Service Application and Remittance
  • Section 1: Organization and Applicant Information
  • Section 2: AOAC Terms & Conditions
  • Section 3: Submission and Method Information
    Application includes Method applicability statement including target analyte(s), Matrix combinations, method instructions, and relevant method safety information.
  • Section 4: Application Fees and Remittance
    Applicant will be invoiced within 2-3 business days of submission.
  • Consulting Service Fees:
    • $3,000.00 USD per method for Non-Organizational Affiliates
    • $2,000.00 USD per method for Organizational Affiliate
    • $1,000.00 USD in addition per method for joint/ harmonized protocols (e.g., PTM-OMA, etc.)
Click here to apply or here to view/print this page in pdf format.

Step 2: Developing Validation Testing Protocols and Plans

  • AOAC provides Technical expertise to draft the validation outline documents and facilitate review process
  • AOAC Guidelines and overview of current technical requirements
  • Appropriate reference materials/methods information Specific validation testing protocols
  • Expert peer review and approval of testing protocols

Step 3: Expert Peer Review and Approval

  • Minimum of three (3) AOAC Expert Review Panel members
  • Statistical review and Safety Review (if applicable)

Step 4: Approved Testing Protocols and Plans

AOAC approved testing protocols are valid for one year from the date of approval.
  • Testing protocol for single laboratory validation study
  • Testing protocol for demonstration of method reproducibility