On-Demand Pill Regulatory Support
This tender is from the country of USA in Americas region. The tender was published by FAMILY HEALTH INTERNATIONAL 360 on 16 Sep 2023 for Request for proposals are invited for On-Demand Pill Regulatory Support. PDI is seeking a CRO for regulatory activities in support of its On-Demand Pill (ODP) product development program. It is anticipated that the selected CRO will: • Prepare, publish, and submit regulatory meeting requests and correspondence on behalf of FHI 360 via electronic submission per accepted electronic common technical document (eCTD) guidance(s). • Perform publishing reviews of entire submissions. This will include format quality checks, document-level publishing quality checks, submission publishing quality checks, and eCTD build and validation. • Provide final, assembled submissions to FHI 360 to review and approve prior to submission to the regulatory authority. • Attend teleconference project meetings with FHI 360 • Perform regulatory gap analyses obtaining market authorization for regulatory pathways of interest in Australia, Switzerland, and India. o Conduct pre-feasibility assessment of conducting a pivotal Phase 3 contraceptive study in Australia, Switzerland and India, if required for marketing authorization. Issue date: 13 Sep, 2023 Closing date: 23 Oct, 2023. The last date to submit your bid for this tender was 23 Oct 2023. This tender is for the companies specializing in IT services and similar sectors.
*The deadline for this tender has passed.
Tender Organisation:
FAMILY HEALTH INTERNATIONAL 360
Tender Sector:
Tender Service:
Worldwide
Tender Region:
Tender Country:
Tender CPV:
72000000 : IT services: consulting, software development, Internet and support
Tender Document Type:
Tender Notice
Tender Description:
Request for proposals are invited for On-Demand Pill Regulatory Support. PDI is seeking a CRO for regulatory activities in support of its On-Demand Pill (ODP) product development program. It is anticipated that the selected CRO will: • Prepare, publish, and submit regulatory meeting requests and correspondence on behalf of FHI 360 via electronic submission per accepted electronic common technical document (eCTD) guidance(s). • Perform publishing reviews of entire submissions. This will include format quality checks, document-level publishing quality checks, submission publishing quality checks, and eCTD build and validation. • Provide final, assembled submissions to FHI 360 to review and approve prior to submission to the regulatory authority. • Attend teleconference project meetings with FHI 360 • Perform regulatory gap analyses obtaining market authorization for regulatory pathways of interest in Australia, Switzerland, and India. o Conduct pre-feasibility assessment of conducting a pivotal Phase 3 contraceptive study in Australia, Switzerland and India, if required for marketing authorization. Issue date: 13 Sep, 2023 Closing date: 23 Oct, 2023
Tender Bidding Type:
Tender Notice No:
Tender Document:
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