Regulatory Affairs Consultant Support Services
Closed Solicitation Posted
This opportunity was awarded. See its 2 award notices in the notice history.
- Solicitation number
- 75N95023R00065
- Agency
- National Institute on Drug Abuse National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- PSC
- R499 Support- Professional: Other
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health National Institute on Drug Abuse seeks regulatory affairs consulting services through solicitation number 75N95023R00065. The contractor shall provide senior-level expertise and guidance to support drug development programs, advising on regulatory strategies and reviewing submissions. Proposals will be evaluated in two phases on personnel qualifications and technical approach, with the deadline for proposals on August 3, 2023. Evaluation will consider experience in drug discovery and development for nervous system conditions.
This acquisition is set aside for small businesses under NAICS code 541690 with a size standard of $16.5 million. The contract has a maximum value of $1,500 per year in reimbursable travel expenses to be performed primarily off-site with occasional on-site work in Bethesda, Maryland over a base period of one year beginning September 2023 with two optional one-year extensions. Evaluation criteria are outlined in Attachments 7 and 7A with amendments provided in Attachments 8 and 9.
Notice text
4 versions
Update #4 · Latest ·
This is Amendment 03. The purpose of this amendment is to post responses to submitted questions via Attachment 09 Amend 3_RFQ_ 75N95023R00065 _Q&A. Please see Attachment 09 Amend 3_RFQ_ 75N95023R00065 _Q&A.
This is Amendment 02. The purpose of this amendment is to post responses to submitted questions via Attachment 08 Amend 2_RFQ_ 75N95023R00065 _Q&A. Please see Attachment 08 Amend 2_RFQ_ 75N95023R00065 _Q&A.
This is Amendment 01. This Amendent is to replace Attachment 7 - EVALUATION CRITERIA with Attachment 7A - EVALUATION CRITERIA Regulatory Affairs. Please see Attachment 7A - EVALUATION CRITERIA Regulatory Affairs.
The NIH is seeking senior-level, industry-experienced drug discovery and development consultants with expertise in small molecules and / or biologics to provide Regulatory Affairs Strategy and document development Consulting services to the following programs:
• Regulatory Affairs consulting to support the NIH Blueprint Neurotherapeutics program [BPN].
• Regulatory Affairs consulting to support the NIH HEAL [Help End Addiction Long term] PTDP [Pain Therapeutics Development Program].
• Other NIH neuroscience-focused drug discovery and development programs.
Update #3 ·
This is Amendment 02. The purpose of this amendment is to post responses to submitted questions via Attachment 08 Amend 2_RFQ_ 75N95023R00065 _Q&A. Please see Attachment 08 Amend 2_RFQ_ 75N95023R00065 _Q&A.
This is Amendment 01. This Amendent is to replace Attachment 7 - EVALUATION CRITERIA with Attachment 7A - EVALUATION CRITERIA Regulatory Affairs. Please see Attachment 7A - EVALUATION CRITERIA Regulatory Affairs.
The NIH is seeking senior-level, industry-experienced drug discovery and development consultants with expertise in small molecules and / or biologics to provide Regulatory Affairs Strategy and document development Consulting services to the following programs:
• Regulatory Affairs consulting to support the NIH Blueprint Neurotherapeutics program [BPN].
• Regulatory Affairs consulting to support the NIH HEAL [Help End Addiction Long term] PTDP [Pain Therapeutics Development Program].
• Other NIH neuroscience-focused drug discovery and development programs.
Update #2 ·
This is Amendment 01. This Amendent is to replace Attachment 7 - EVALUATION CRITERIA with Attachment 7A - EVALUATION CRITERIA Regulatory Affairs. Please see Attachment 7A - EVALUATION CRITERIA Regulatory Affairs.
The NIH is seeking senior-level, industry-experienced drug discovery and development consultants with expertise in small molecules and / or biologics to provide Regulatory Affairs Strategy and document development Consulting services to the following programs:
• Regulatory Affairs consulting to support the NIH Blueprint Neurotherapeutics program [BPN].
• Regulatory Affairs consulting to support the NIH HEAL [Help End Addiction Long term] PTDP [Pain Therapeutics Development Program].
• Other NIH neuroscience-focused drug discovery and development programs.
Update #1 ·
The NIH is seeking senior-level, industry-experienced drug discovery and development consultants with expertise in small molecules and / or biologics to provide Regulatory Affairs Strategy and document development Consulting services to the following programs:
• Regulatory Affairs consulting to support the NIH Blueprint Neurotherapeutics program [BPN].
• Regulatory Affairs consulting to support the NIH HEAL [Help End Addiction Long term] PTDP [Pain Therapeutics Development Program].
• Other NIH neuroscience-focused drug discovery and development programs.
Attachments
Show all 11
Notice history
| Notice | Type | Posted |
|---|---|---|
| Regulatory Affairs Consultant Support Services | Award Notice | |
| Regulatory Affairs Consultant Support Services | Award Notice | |
| Regulatory Affairs Consultant Support Services | Solicitation |
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