On-Demand Pill Regulatory Support - 3564861
The FAMILY HEALTH INTERNATIONAL 360 in USA from Americas region had released this tender 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 with tender notice no. 140257_CRO_1_RFP_02 published on 16 Sep 2023. The tender expired on 23 Oct 2023. This tender is sourced from Official Website and is eligible for suppliers interested in IT services. Interested bidders can obtain further information including complete bid documents or ways to participate by registering on Tender Impulse and referencing via Tender Impulse ID 3564861.
*The deadline for this tender has passed.
Tender Notice No:
140257_CRO_1_RFP_02
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 Document:
- 1 week to go
- 15 Days to go
- More than 15 days to go
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Common Questions About This Tender
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Who has issued this tender, and what is it for?
The tender has been issued by FAMILY HEALTH INTERNATIONAL 360 in USA. Such a type of tender falls under IT services, within the Consultancy sector, and is listed on Tender Impulse under notice number 140257CRO1RFP02.
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What are the key dates for this tender?
The notice was published on 16 Sep 2023 and submissions close on 23 Oct 2023. Late bids are rarely accepted in public procurement, so aim to have your documents ready several days before the closing date.
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Which CPV codes apply to this tender?
It is classified under CPV codes 72000000, which correspond to IT services. If your company supplies these products or services, these are the codes to save in your alert profile so no matching tender passes you by.
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Can I submit my bid for this tender to Tender Impulse?
No - and this matters. Tender Impulse is a tender aggregation and alert service: we collect procurement notices from official sources around the world and list them in one place. We do not receive, forward or evaluate bids. Your bid for this tender must be submitted directly to FAMILY HEALTH INTERNATIONAL 360, using the method described in the original tender document, before 23 Oct 2023. Tender Impulse provides complete assistance in submitting all bids posted on its website.
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How do I get the bid documents and participation details?
Request a live demo on Tender Impulse and our tender experts will walk you through this listing, share the available documents, and explain how to submit your bid to FAMILY HEALTH INTERNATIONAL 360. Subscribers also receive help with registration requirements and, where needed, translation of non-English notices - but the submission itself always goes from you to the buyer.
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How to prepare for this bid?
Suppliers must verify technical specifications, the delivery schedules and any other intrinsic details as provided in the complete bid documents before deciding to submit their bids. All necessary certifications and supplier registrations must be undertaken before participation.
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Is this tender beneficial for me?
The procurement is applicable to companies in the IT services and related industries. If you belong to this industry, you can review the technical documents before assessing your relevance to your company.
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What is the Procurement trend for On-Demand Pill Regulatory Support?
The public procurement trends for On-Demand Pill Regulatory Support can be assessed by viewing historical data and buying patterns for this product. Subscribed members can view and even download reports of tenders released in the past for their market research. This shall allow them to carefully prepare a compelling bid.
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