Frequently Asked Questions About BioAgilytix

• Confidentiality (CDA) or Non-Disclosure Agreement (NDA) is executed
• Developmental Services Agreement (DSA) is established
• Pricing proposal is prepared by our Project Operations Department based on the RFP and/or protocol for the project
• Final contract is executed and your project team is assigned (dedicated Principal Investigator, Project Coordinator, and Project Assistant)
• Samples are sent to MicroConstants and analyzed per the timeline specified in the contract
• Preliminary data is sent through quality control (QC)
• QC’d data is released to the client and report preparation is initiated
• Report is audited by our Quality Assurance Unit (QAU), if applicable
• Draft report is submitted to the client for review
• Report is finalized and client comments are incorporated

Every client is assigned a dedicated Project Coordinator and Principal Investigator for their projects.

Project Coordinator:

• Serves as the main point of contact throughout the duration of the project
• Works with you to develop a project execution plan
• Provides continuous status updates
• Monitors the progress of each project to ensure timelines are being met

Principal Investigator:

• Interprets, analyzes, documents, and reports all project results
• Works with our analysts to troubleshoot any problems that may arise
• Collaborates with you and the study site(s) to ensure the protocol is being followed and the samples are correctly analyzed and reported

BioAgilytix is in compliance with the following regulatory agency guidelines:

• United States Food and Drug Administration (USFDA), Title 21 Code of Federal Regulations Part 58, Good Laboratory Practices (GLP)
• Organisation for Economic Co-operation and Development (OECD), Principles of Good Laboratory Practices (GLP) [ENV/MC/CHEM (98)17]
• Japanese Ministry of Health, Labor and Welfare (MHLW), Good Laboratory Practice Standards (GLP Ordinance 21)

Prior to beginning a formulation validation project, the following information will need to be provided:

• Vehicle composition and preparation
• Dose range to be validated
• Correction factor to be used at the toxicology facility
• Salt form and structure of the test article
• Any unusual steps planned for the preparation of the formulation (i.e. mixing overnight, dropwise additions, etc.)
• Planned storage conditions

If any of these changes from one study to the next, additional validation work may be required for subsequent studies. Therefore, we recommend that the initial validation parameters are broad enough to account for likely alterations.