SBA Profile
Privacy StatementIdentification, Location & Contacts
This profile was last updated:
10/23/2024
Status:
Active
User ID:
P0598813
Name of Firm:
SMART CONSULTING GROUP LLC
Capabilities Statement Link:
Trade Name ("Doing Business As ..."):
UEI:
EAZXL6WGGEN5
Address, line 1:
420 W MINER ST
Address, line 2:
City:
WEST CHESTER
State:
PA
Zip:
19382-2835
Phone Number:
610-344-9217 x
Fax Number:
610-344-9219
E-mail Address:
E-Commerce Website:
Contact Person:
DENISE SMART
County Code (3 digit):
029
Congressional District:
06
Metropolitan Statistical Area:
6160
CAGE Code:
304U6
Year Established:
1999
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:
LLC
Ownership and Self-Certifications:
Women-Owned Small Business, Woman Owned
Current Principals
1. Denise Smart, President
“Business Development Servicing Office” (for certifications)
PHILADELPHIA DISTRICT OFFICE (SBA office code 0303)
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?:
[X] Yes [ ] No
WOSB Certification Date:
11/15/2022
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:
(none given)
Products & Services
Capabilities Narrative:
Smart Consulting Group is a progressive consulting company that is providing technical, quality compliance and regulatory assistance to the healthcare industry with specific focus on:
?Pharmaceuticals
?Biotechnology
?Biologics
?Medical Devices
Services include:
* Subject Matter Expert Support for medical product development and licensure, including CBRN products
* Development of a Quality Strategy
* Building comprehensive Quality Systems together with implementation of integrated Quality System Elements
* Experience with global concerns and implementation
* Change Management, Investigations, CAPA, OOS, document systems, audits, risk management and GMP information system support.
Compliance Remediation Programs for FDA483’s, Warning Letter and Consent Decrees/Application Integrity Policy.
Custom courses are available for a variety of topics as well as individual mentoring type coaching, which provides experienced one-on-one training and guidance
Special Equipment/Materials:
(none given)
Business Type Percentages:
Research and Development (20 %)
Service (80 %)
Service (80 %)
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 | "Buy Green"? (1) | Small? (2) | |
|---|---|---|---|---|---|---|
| 1 | Yes | 541611 | Administrative Management and General Management Consulting Services | Yes | ||
| 2 | 541330 | Engineering Services General $22.50m Small Business Size Standard: [Yes] Special $41.50m Military and Aerospace Equipment and Military Weapons: [Yes] Special $41.50m Contracts and Subcontracts for Engineering Services Awarded Under the National Energy Policy Act of 1992: [Yes] Special $41.50m Marine Engineering and Naval Architecture: [Yes] (4) |
Yes | |||
| 3 | 541612 | Human Resources Consulting Services | Yes | |||
| 4 | 541614 | Process, Physical Distribution and Logistics Consulting Services | Yes | |||
| 5 | 541618 | Other Management Consulting Services | Yes | |||
| 6 | 541690 | Other Scientific and Technical Consulting Services | Yes | |||
| 7 | 541714 | Research and Development in Biotechnology (except Nanobiotechnology) | 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 | 541990 | All Other Professional, Scientific and Technical Services | Yes | |||
| 10 | 611430 | Professional and Management Development Training | Yes | |||
|
(1) By entering Yes for "Buy Green",
the firm asserts that it obeys EPA guidelines for environmental friendliness for this NAICS code.
Note, EPA guidelines do not exist for every NAICS code. (2) If Yes, the firm's revenues/number of employees do not exceed the NAICS code's small business size standard. (4) As seen above, the size standard can depend on subcategories within a NAICS code. |
||||||
Keywords:
FDA Regulatory Affairs, FDA compliance, Biotechnology Products, Vaccines, Expert Witness, Quality Systems, FDA Consent Decree, Pharmaceuticals, Manufacturing, Medical Product Development, Medical Device regulation, Analysis of Alternatives, Medical Product Manufacturing, Biosafety, Pharmaceutical Investigations and CAPA
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:
Conceptual Mindworks, Inc
Contract:
HHSO100201100003I
Start:
04/08/2011
End:
01/31/2018
Value:
$883,762.00
Contact:
Phone:
Name:
Tunnell Government Services
Contract:
HHSO100201100003I
Start:
04/08/2011
End:
01/31/2018
Value:
$2,947,055.80
Contact:
Phone:
Name:
Joint Program Executive Office for Chemical and Biological Defense
Contract:
16-233-SOL-00006
Start:
03/14/2016
End:
09/01/2019
Value:
$4,271,027.64
Contact:
Phone:
Name:
FDA
Contract:
HHSF223201610432G
Start:
09/09/2016
End:
09/28/2020
Value:
$638,903.37
Contact:
Phone:
The structure of this page was last updated 02/01/2013, as part of SBSS 8.1.1.