Regulatory support

Regulatory guidance is essential as you begin the endocrine disruptor screening program (EDSP) process.  Regulators have stringent expectations and guidelines, and you need a knowledgeable partner who can help you to meet all the regulatory submission requirements for EDSP.  At Envigo, our experienced consultants provide you with clear regulatory advice, so you can feel confident that you are completing all required EDSP assays. Our experts have traditionally offered our agrochemical and industrial chemical customers a complete set of services that includes dossier preparation and support as well as data gap analysis and advice on testing needed to support a registration or other regulatory submission. We put this depth of experience to work for you and your EDSP requirements.

Our experts have already managed several complete EDSP testing programs (full set of in vitro and in vivo tests) and a number of in vitro only programs. In addition to their EDSP work, our consultants have been responsible for the management, submission and defense of over 15 new agrochemical development substances and numerous challenging re-registration programs.

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  • Fulfilling the data requirements including program management, if required
  • Expert consultancy
  • Preparation of weight of evidence (WOE) documents
  • Preparing the other significant relevant information document (OSRI) recommending on testing required and the lab(s) to perform the testing
  • Consortium set up or representation
  • Post-submission support

Our consultants review all relevant data available to your researchers and/or available in the public domain and prepare an overview report. Based on this data gap analysis, any waivers or studies are identified and additional studies are recommended.  The extent of the work is dependent on the volume of data and quality of the studies available for each substance. Typically we:

  • Expect to receive about 10 regulatory studies that would be reviewed against EDSP criteria
  • Conduct a literature search
  • Review relevant published literature
  • Provide a full OSRI report

Consortium set up or representation

Envigo is able to assist you in communicating with other test order recipients and, when desired, setting up consortia. Our staff is experienced in managing such consortia and providing the administrative technical and scientific support required during the process. Alternatively, our Envigo expert staff can represent your organization within an existing consortium.

Fulfilling data requirements and program management

Envigo experts are able to support the conduct of your studies whether they are performed at our laboratories or at another facility. We can manage your program, monitor your studies and provide regular updates as required by the sponsor, something essential in critical result identification and target management.

If you require a full set of studies, we can assign a dedicated program manager to oversee the program of studies required to fulfill the requirements of the regulatory dossier.  Our program manager may also be the consultant responsible for the appropriate registration dossier.

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  • Acts as the focal point of contact for your program
  • Coordinates effective communications within the operational laboratories and with you regarding the key objectives
  • Acts as your advocate
  • Represents you to monitor and report on study progress. Regular status updates/reports are provided.
  • Ensures the program is managed within budget and on time, or with changes as agreed
  • Recommends any additional action to ensure the program/project timeline is maintained in a cost effective manner to meet your objectives
  • Coordinates expert consultancy input to ensure timely interpretation of study results in the context of current regulatory requirements
  • Requesting test substance
  • Ensuring all data on the substance are self-consistent
  • Requesting protocols
  • Preparation of a monthly status report
  • Ensuring correct reporting
  • Preparation of weight of evidence (WOE) document when all studies are in hand
  • Post submission support and, if needed, representation and/or support in your discussions with the EPA following the submission of the data and WOE as questions may arise

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