| Capabilities Statement Link |
https://www.qualitysystemsservices.com/_files/ugd/c7b284_6e8e652037994c5693e83565e3de6f38.pdf
|
| Phone Number |
845-596-9666
|
| Fax Number |
-
|
| E-mail Address |
kwallbank@qualitysystemsservices.com
|
| WWW Page |
https://www.qualitysystemsservices.com/
|
| E-Commerce Website |
https://www.qualitysystemsservices.com/
|
| Contact Person |
KIMBERLY WALLBANK
|
| County Code (3 digit) |
119
|
| Congressional District |
16
|
| Metropolitan Statistical Area |
5600
|
| CAGE Code |
9WTD3
|
| Year Established |
2010
|
| Accepts Government Credit Card |
Yes
|
| Legal Structure |
LLC
|
| Ownership and Self-Certifications |
Women-Owned Small Business, Woman Owned
|
| Business Development Servicing Office |
NEW YORK DISTRICT OFFICE (SBA office code 0202)
|
| Capabilities Narrative |
Quality Systems Services, LLC is a small consulting firm that works with pharmaceutical and medical device companies to navigate the complexities of compliance.
We are committed to assisting FDA-regulated companies in creating and maintaining a well-functioning quality system to ensure compliance with standards and regulations, improve product or service quality, reduce costs, enhance customer satisfaction, and promote continuous improvement and innovation.
Core Competencies
Quality System Implementation
Quality System Remediation
Audit Support
FDA Commitment Resolution
Differentiators
Provides solutions tailored to specific business needs.
Successfully completed multiple FDA commitments
Certified as a Certified Quality Auditor through ASQ
|
| Special Equipment/Materials |
None
|
| Business Type Percentages |
Service (100 %)
|
| Keywords |
quality, quality system, quality systems, quality assurance, audit, audits, FDA, NIH, CDC, complaint, training, remediation, implementation, inspection, readiness, validation, deviation, investigation, CAPA, ISO13485, ISO 13485, 21CFR210/211, 21CFR820, pharmaceutical, medical device, med device, pharma, biotech, medtech, combination products, cosmetics
|
| Quality Assurance Standards |
(none given)
|
| Electronic Data Interchange capable |
-
|
Current Principals
| Name |
Kimberly Wallbank |
| Role |
Owner/Founder |
|
SBA Federal Certifications
| HUBZone Certified |
No |
| Women Owned Certified |
Yes |
| Women Owned Pending |
No |
| Economically Disadvantaged Women Owned Certified |
No |
| Economically Disadvantaged Women Owned Pending |
No |
| Veteran-Owned Small Business Certified |
No |
| Veteran-Owned Small Business Joint Venture |
No |
| Service-Disabled Veteran-Owned Small Business Certified |
No |
| Service-Disabled Veteran-Owned Small Business Joint Venture |
No |
Bonding Levels
| Description |
Construction Bonding Level (per contract) |
| Level |
$0 |
|
| Description |
Construction Bonding Level (aggregate) |
| Level |
$0 |
|
| Description |
Service Bonding Level (per contract) |
| Level |
$0 |
|
| Description |
Service Bonding Level (aggregate) |
| Level |
$0 |
|
NAICS Codes with Size Determinations by NAICS
| Primary |
Yes |
| Code |
541690 |
| NAICS Code's Description |
Other Scientific and Technical Consulting Services |
| Buy Green |
Yes |
|
| Code |
541990 |
| NAICS Code's Description |
All Other Professional, Scientific and Technical Services |
| Buy Green |
Yes |
|
Export Profile (Trade Mission Online)
| Exporter |
No |
| Export Business Activities |
(none given) |
| Exporting to |
(none given) |
| Desired Export Business Relationships |
(none given) |
| Description of Export Objective(s) |
(none given) |
|
