1064211-event.pdf

02 May 2022

MilTech Regulatory & Compliance Subject Matter Experts: FDA, NIOSH, and/or ISO Compliance MilTech is seeking Regulatory and Compliance Subject Matter Experts in one or more of the following areas: FDA, NIOSHA, and/or ISO Compliance.

02 May 2022

Open 3/21/2022 8:00 AM MDT Type Request for Proposal Close 4/19/2022 2:00 PM MDT Number MSU-RFP-22-22 Currency US Dollar

Sealed Until 4/19/2022 2:00 PM MDT

Payment Terms 0% 0, Net 30

02 May 2022

Contacts Kimberly Casper kimberly.casper@montana.edu

Phone +1 406-994-3211

02 May 2022

Commodity Codes Commodity Code Description 2614 Health Related - Medical Research 2607 Health Related - Hospital Equipment 2608 Health Related - Hospital Supplies 2609 Health Related - Institutional Equipment 2610 Health Related - Institutional Supplies 2611 Health Related - Medicaid Analysis & Audit 2613 Health Related - Medical Services 2617 Health Related - Pharmaceuticals 2618 Health Related - Services 2619 Health Related - Supplies 4303 Safety - Services

02 May 202202 May 202202 May 202202 May 202202 May 202202 May 202202 May 202202 May 202202 May 2022 mailto:kimberly.casper@montana.edu

The MilTech department at Montana State University is a US government, Office of the Secretary of Defense, Office of Technology Transition Partnership Intermediary and provides hands-on product design, prototyping, technology scouting, and manufacturing assistance to the US government and non-traditional defense suppliers and small companies in order to transition innovative technology to the US government rapidly, reliably, and cost-effectively.

The University is seeking qualified contractors able to provide MilTech Regulatory and Compliance Subject Matter Expertise Services to support project deliverables. Interested vendors may submit a proposal to one, two, or all three of the Service Categories in this RFP: FDA, NIOSH, and/or ISO Standards Compliance. MilTech anticipates that one or more contracts may be awarded, at MilTech's discretion.

Description

Required to View Event

Prerequisites Required to Enter Bid

02 May 2022

1. Review and accept the single point of contact information.

2. Review and accept the University's instructions for submitting a proposal.

3. Review and accept the contract term.

4. Review and accept our RFP general information.

5. Review the University's special terms and conditions.

6. Review and accept the University's insurance requirements.

7. Review and accept the instructions and schedule for the Offerors' Questions and University's Response.

8. Review and accept the minimum score requirement.

9. Review and accept the University's Intellectual Property clause.

10. Review and accept the University's Right to Investigate and Reject clause.

11. Review and accept the University's Mandatory Requirements clause.

12. Review and accept the University's Debarment clause.

13. Review and accept the University's export control clause

14. Review and accept the Safeguarding Covered Defense Information Controls.

15. Review and accept the Special Security Requirement.

16. Review and accept the MilTech Contract and Task Order Special Information, 17.

Review and accept the attached Contract. Requests for additions or exceptions to the Contract terms, including any necessary licenses, or any added provisions must be submitted to the Procurement Officer referenced above by the date for receipt of questions, as stated in the Schedule of Events. Any request must be accompanied by an explanation of why the exception is being sought and what specific effect it will have on the Offeror’s ability to respond to the RFP or perform the Contract. The University will make any final determination of changes to the standard terms and conditions and/or contract.

02 May 202202 May 202202 May 202202 May 202202 May 202202 May 202202 May 2022

Buyer Attachments

1. Scope of Work Regulatory & Compliance Subject Matter Experts - FDA, NIOSH, ISO Compliance.docx

02 May 202202 May 202202 May 202202 May 202202 May 202202 May 2022 https://s3.amazonaws.com/solutions-selectsite-documents/Sourcingevent/1064211-1220443615Scope%20of%20Work%20Regulatory%20%26%20Compliance%20Subject%20Matter%20Experts%20-%20FDA%20NIOSH%20ISO%20Compliance.docx?AWSAccessKeyId=AKIAJ5HNJE5DFBZ5ONSA&Expires=1714602003&Signature=UwTWZ8lxY8OaJvTty3kH%2BMXhIdA%3D

Questions Required Questions

Group 1: General Instructions:

1.1 I understand it is my responsibility to check the Public Q&A board before submitting my proposal.

1.2 I understand that to ensure my questions will be answered, they should be submitted to the public Q&A board by April 4, 2022 at 2:00 pm MST. Questions may be submitted after this deadline but there is no guarantee that late questions will be answered.

1.3 Submit a current W-9.

1.4 Provide contact information for the contract liaison: __________ is Contractor's liaison.

(Address): (City, State, ZIP): Telephone: Cell Phone: Fax: E-mail:

1.5 Provide name, title and email address for Contract signatory.

1.6 The University routes Contracts for signature via DocuSign. Please provide names & emails for additional personnel that should receive a copy of the Contract within your company, other than the Contract’s liaison or signatory stated above.

1.7

Equal Pay for Montana Women. Executive Order No. 12-2016 promoting equal pay for Montana women directs the Department of Administration to include incentives in the RFP process for contractors who engage in best practices to promote wage transparency. These best practices include the following:

(a)posting salary ranges in employment listings;

(b)certifying that the contractor will not ask about wage history in employee interviews;

(c)certifying that the contractor will not retaliate or discriminate against employees who discuss or disclose their wages in the workplace.

Offeror indicating it will comply with Executive Order No. 12-2016 will receive 5% of the total points available. Offerors who do not comply will not receive the available points.

Group 2: Requirements Instructions:

2.1 Indicate which Service Category(ies) you are responding to.

2.2

REFERENCES: Upload a minimum of three (3) references that have used the services of the type proposed in this RFP, preferably within the last three (3) years. These references may be contacted to verify Offeror’s ability to perform the contract. The University reserves the right to use any information or additional references deemed necessary to establish the ability of the Offeror to perform the conditions of the contract.

Negative references may be grounds for proposal disqualification.

If responding to multiple categories, upload a single document with clearly separate, complete responses, identifying the applicable service category for each section in your response.

2.3

YEARS OF EXPERIENCE & PAST PROJECTS: Upload a narrative statement explaining (1) how long the company has been in the business of providing services similar to those requested in the Buyer Attachments, Scope of Work, Section 2 Services Category Descriptions, and (2) a complete description of relevant past projects within the last 1-3 years that clearly demonstrate company experience with all the requirements described in Sections 2 and 3, Requirements.

If responding to multiple categories, upload a single document with clearly separate, complete responses, identifying the applicable service category for each section in your response. Additionally: If responding to Category A, include examples of successful submissions with the FDA. If responding to Category B, include a list of all NIOSH regulations for which the company can provide expertise. If responding to Category C, include a list of all ISO standards for which the company can provide expertise.

2.4

KEY PERSONNEL QUALIFICATIONS: Upload a single PDF file of resumes or summary of qualifications, work experience, certifications, education, skills, etc. which emphasizes previous experience similar to those requested in the Buyer Attachment Scope of Work, Section 2 Service Category Descriptions and Section 3, Requirements, for all key personnel who will be involved with any aspect of the contract. When calculating years of experience, include only those years that each employee has worked directly with the types of services shown on this RFP.

Group 3: Evaluation Criteria Instructions:

3.1 I understand the RFP will be evaluated based on the scoring criteria attached.

02 May 202202 May 202202 May 202202 May 202202 May 2022

Product Line Items Product Line Items

There are no Items added to this event.

02 May 202202 May 202202 May 202202 May 2022

Service Line Items Service Line Items

1. Hourly Rate Proposal # Item Name, Commodity Code, Description Allow

Alternates Qty. UOM Requested Service Delivery

S1 Service Category A: FDA Hourly Rate 1 HR - Hour

The resulting contract(s) for vendors awarded under this RFP will reflect a single hourly rate per Service Category. For companies with multiple labor categories, a single, blended rate should be calculated and used for each Service Category.

S2 Service Category B: NIOSH Hourly Rate 1 HR - Hour

S3 Service Category C: ISO Compliance Hourly Rate 1 HR - Hour

02 May 202202 May 202202 May 2022