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.
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.