SBA Profile

Privacy Statement

Identification, Location & Contacts

This profile was last updated:
02/20/2025
Status:
Active

User ID:
P2588182
Name of Firm:
FDA CONNECTION GROUP INC
Capabilities Statement Link:
Trade Name ("Doing Business As ..."):
UEI:
C3A4PAHVBLU1
Address, line 1:
7830 E CAMELBACK RD UNIT 410
Address, line 2:
City:
SCOTTSDALE
State:
AZ
Zip:
85251-2236
Phone Number:
571-246-3142 x
Fax Number:
E-mail Address:
E-Commerce Website:
Contact Person:
NATE WILLIAMS
County Code (3 digit):
013
Congressional District:
01
Metropolitan Statistical Area:
6200
CAGE Code:
8VUG8
Year Established:
2020
Accepts Government Credit Card?:
[X] Yes [  ] No
GSA Advantage Contract(s):
Check for Buy GSA Contracts

(Note: Size information is now under "NAICS Codes with Size Determinations by NAICS", below.)


Organization, Ownership & Certifications

Legal Structure:
Subchapter S Corporation
Ownership and Self-Certifications:
Black American, Other Minority Owned

Current Principals

1. Geoffrey Nate Williams, President/CEO

“Business Development Servicing Office” (for certifications)

ARIZONA DISTRICT OFFICE (SBA office code 0988)

SBA Federal Certifications

SBA has verified the following certifications in DSBS: 8(a), HZ, WOSB, EDWOSB, VOSB, SDVOSB. Any other certification presented in DSBS is self-certified by a firm and not verified by SBA. Contracting officers should diligently review a bidder's small business self-certifications before awarding a contract.

8(a) Certification:

SBA 8(a) Case Number:
SBA 8(a) Entrance Date:
SBA 8(a) Exit Date:

HUBZone Certification:

HUBZone Certified?:
[  ] Yes [X] No
HUBZone Certification Date:

8(a) Joint Venture - SBA Certified:
NOTE: Notify your servicing SBA Business Opportunity Specialist to have your 8(a) joint venture approval date reflected in DSBS.

8(a) JV Entrance Date:
8(a) JV Exit Date:

Women Owned - SBA Certified:

WOSB Certified?:
[  ] Yes [X] No
WOSB Pending?:
[  ] Yes [X] No

Economically Disadvantaged Women Owned - SBA Certified:

EDWOSB Certified?:
[  ] Yes [X] No
EDWOSB Pending?:
[  ] Yes [X] No

Veteran-Owned Small Business - SBA Certified:

VOSB Certified?:
[  ] Yes [X] No
VOSB Joint Venture?:
[  ] Yes [X] No
VOSB Certification Date:
VOSB Certification Expiration Date:

Service-Disabled Veteran-Owned Small Business - SBA Certified:

SDVOSB Certified?:
[  ] Yes [X] No
SDVOSB Joint Venture?:
[  ] Yes [X] No
SDVOSB Certification Date:
SDVOSB Certification Expiration Date:

Other Certifications

Non-Federal-Government Certifications:

GMP
GCP

Products & Services

Capabilities Narrative:

FDA Connection Group, Inc. is a 3rd party FDA consulting group specializing in analytical, clinical, regulatory, and compliance affairs specific to FDA approvals for our Clients. Our Team is proficient in writing Investigational New Drug Applications, Clinical Trial Strategy, Auditing, and Monitoring plans as well as certified in Good Clinical Practices, Good Manufacturing Practices, and Good Laboratory Practices. Most importantly, we fully understand and capable of translating to our clients FDA Quality System Regulations and Compliance, International Conference on Harmonization, and International Organization for Standardization (IND,GCP/GMP/GLP/QSR/ICH/ISO) requirements for the Pharmaceutical, Medical Device, and Biologic industries.

Special Equipment/Materials:

(none given)

Business Type Percentages:

Service (100 %)

Bonding Levels

Construction Bonding Level (per contract)
$0
Construction Bonding Level (aggregate)
$0
Service Bonding Level (per contract)
$0
Service Bonding Level (aggregate)
$0

NAICS Codes with Size Determinations by NAICS:

# Primary? Code NAICS Code's Description Small? (1)
1 Yes 541714 Research and Development in Biotechnology (except Nanobiotechnology) Yes
2   325413 In?Vitro Diagnostic Substance Manufacturing Yes
3   325414 Biological Product (except Diagnostic) Manufacturing Yes
4   541380 Testing Laboratories and Services Yes
5   541611 Administrative Management and General Management Consulting Services Yes
6   541618 Other Management Consulting Services Yes
7   541690 Other Scientific and Technical Consulting Services Yes
8   541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
General 1000 Employees Small Business Size Standard: [Yes]
Special 1500 Employees Aircraft, Aircraft Engine and Engine Parts: [Yes]
Special 1250 Employees Other Aircraft Parts and Auxiliary Equipment: [Yes]
Special 1250 Employees Guided Missiles and Space Vehicles, Their Propulsion Units and Propulsion Parts: [Yes] (4)
Yes
9   541720 Research and Development in the Social Sciences and Humanities Yes
10   541990 All Other Professional, Scientific and Technical Services Yes
11   561990 All Other Support Services Yes
12   621511 Medical Laboratories Yes
(1) If Yes, the firm's revenues/number of employees do not exceed the NAICS code's small business size standard.
(3) As seen above, the size standard can depend on subcategories within a NAICS code.

Keywords:

Good Manufacturing Practices, Good Clinical Practices, IND, Investigational New Drug, CAPA, NDAs, ANDAs, Pre-Market Approvals, PLAs, BLAs, 510ks, GMP, GCP, RA/QA, Regulatory Affairs, Quality Assurance, QA/RA, PMA, GLP, Good Laboratory Practices

Miscellaneous:

Quality Assurance Standards:
(none given)
Electronic Data Interchange capable?:
[  ] Yes [  ] No

Export Profile (Trade Mission Online)

Exporter?:
[  ] Yes [X] No [  ] Wants To Be
Export Business Activities:
(none given)
Exporting to:
(none given)
Desired Export Business Relationships:
(none given)
Description of Export Objective(s):
(none given)

Performance History (References)



Name:
Arizona State University
Contract:
clinical trials
Start:
06/06/2020
End:
Value:
Contact:
Jim Adams
Phone:
480-818-0741


Name:
R3 Stem Cell
Contract:
IND Documentation
Start:
10/15/2020
End:
Value:
Contact:
Dr. David Greene
Phone:
602-677-8981


The structure of this page was last updated 02/01/2013, as part of SBSS 8.1.1.