AOAC Official Methods Program - Consulting Services

OMA PROGRAM & SERVICES – APPLICATION OVERVIEW

ONLINE APPLICATION

LINK

CONSULTING SERVICES ONLINE APPLICATION OFFICAL METHODS PROGRAM ONLINE APPLICATION

SECTION 1A: APPLICANT CONTACT INFORMATION Please note that this application must be completed and submitted by the contact that is authorized by the organization to pursue and obtain validations and/or development of protocols. All correspondence in relation to this application will be directed to the contact listed in this section.  First & Last Name  Organization  Email *  Phone Number *  Address SECTION 1B: FINANCIAL CONTACT INFORMATION Please provide the contact information for the person within your organization that will be responsible for receiving and processing the payments for invoicing.  First and Last Name  Email  Phone Number SECTION 2: TERMS & CONDITIONS Please read all the Terms and Conditions, AOAC International Policy Documents (Use of Association Name, Anti-Trust, Volunteer Conflict of Interest, and the associated Fee Schedule.  By completing and submitting this application, you are agreeing to the Terms and Conditions stated above: SECTION 3: SUBMISSION & METHOD INFORMATION The following information below will assist with detailing the method information that will be required for your submission for Consulting Services and the AOAC Official Methods of Analysis SM Program. CONSULTING SERVICES APPLICATION SECTION 3A: SUBMISSION INFORMATION  For which method assessment program is/are testing protocols to be developed.

 AOAC Official Methods Program- Sole Source Methods  AOAC Official Methods Program- Proprietary Methods  AOAC Official Methods Program - Standards Development (AOAC SMPR) • SMPR No.

 Please indicate the method type:  New Method  Method Modification  Please indicate the type of protocol(s) requested:  Single Laboratory Validation  Multi-Laboratory /Collaborative Validation  Analysis Type

 Qualitative  Quantitative  Reference Methods, if applicable. SECTION 3B: METHOD INFORMATION  Legal Name of Method  Analyte(s)

 Matrice(s)  Method Applicability and Intended Use

SECTION 3C: METHOD DOCUMENTATION & UPLOADS Please upload all required documentation. Multiple files may be uploaded in each section noted below. File sizes must be less than 100MB each. Scanned copies must be clearly legible.  Method User Guides/Package Inserts/Method Steps  Supplemental Documents

www.aoac.org

OMA PROGRAM & SERVICES – APPLICATION OVERVIEW

OMA PROGRAM APPLICATION SECTION 3A: SUBMISSION INFORMATION  Please select the method assessment program for which this method will be reviewed:  AOAC Official Methods Program- New Method  AOAC Official Methods Program- Method Modification  Please indicate the type of proposed modification:

  Please indicate the method submission type:  Sole Source Method/Non-Proprietary  Proprietary Method  Call for Methods (Not currently available)  Please indicate the type of protocol(s) requested:  Single Laboratory Validation  Multi-Laboratory /Collaborative Validation  Analysis Type  Qualitative  Quantitative SECTION 3B: METHOD INFORMATION  Legal Name of Method  Analyte(s)

 Matrice(s)  Method Applicability and Intended Use

 For Modifications:

 Summarize the Proposed Modification  Describe how the modification will be evaluated SECTION 3C: METHOD DOCUMENTATION & UPLOADS Please upload all required documentation. Multiple files may be uploaded in each section noted below. File sizes must be less than 100MB each. Scanned copies must be clearly legible.  Method Manuscript/Method  Protocol(s)  Method User Guides/Package Inserts/Method Steps  Supplemental Documents

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AOAC CONSULTING SERVICES

AOAC CONSULTING SERVICES AOAC Official Methods SM Program (OMA) Validation Testing Protocols and Plans

AOAC INTERNATIONAL is announcing an expansion of accessibility to the AOAC Consulting Service for all method authors. Our consulting services are designed to develop and provide complete individualized approved validation outlines for method developers aspiring to submit their methods to the Official Methods SM (OMA) 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. This will include all pertinent testing protocols, acceptance criteria, and information on reference materials or reference methods for single laboratory and/or multi- laboratory validations, 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 Methods SM 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.

Step 1: Submit an Online Application 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.

www.aoac.org

AOAC CONSULTING SERVICES

• Section 4: Application Fees and Remittance Applicant will be invoiced within 2-3 business days of submission. • Consulting Service Fees: o $3,000.00 USD per method for Non-Organizational Affiliates o $2,000.00 USD per method for Organizational Affiliate o $1,000.00 USD in addition per method for joint/ harmonized protocols (e.g., PTM-OMA, etc.) 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.

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