OVERVIEW:Quality Solutions, LLC is a bio-technology contracting and consulting company founded in 2001 with

clients throughout the United States and abroad. Quality Solutions provides technical services for clients

that must meet regulatory and quality assurance guidelines in a cost-effective and streamlined manner.

CORE COMPETENCIES:The company specializes in offering a Turn-Key solution in order for clients to consolidate vendors.

Quality Solutions, LLC manages and executes multiple aspects of a project including project management,

commissioning activities, calibration, environmental monitoring, and qualifi cation/validation. The result is

an integrated solution that streamlines qualifi cation processes and improves client productivity.

Quality Solutions illustrates its commitment to offering the highest degree of quality to the client by

leveraging advanced testing technologies and industry-accepted equipment to provide increased utility

to the client. A comprehensive Quality System further ensures staff training, continual improvement and

compliance with cGMP, GxP and other FDA regulations.

PRINCIPALS:Brian Frederick

Jeff Lange

Edward J. Sybert

CORE SERVICES:Validation

Preparation and Execution Validation Master Plans

Validation Project Management

Preparation and Execution of Validation Protocols

Facility, Utility, Equipment, Software Qualifi cation

Design Services, Construction Managementand Commissioning

Sterilization Cycle Development and Validation

CONTACT INFORMATION:Jeff Lange, Vice President

Business Development

Tel: 410-852-5267

Fax: 410-823-5226

Email: info@qualsolve.net

www.qualsolve.net

DIFFERENTIATORS:• Turn-Key services

• NSF certifi ed technicians

• State of the art testing equipment

• Ensure return on the cost of quality

• Experience with facility design, commissioning, validation and regulatory compliance. CGMP Process Evaluation, Optimization, and Compliance.

Capabilities Statement

Client/Agent Services

Project Management

Vendor and Contractor Management

Commissioning Execution and Start-up Services

CORE SERVICES Continued :

PREVIOUS EXPERIENCE: • CDC Atlanta, Subcontractor for McCarthy Building Companies, Inc., October, 2005

• NIH’s National Institute on Drug Abuse (NIDA) and National Institute on Aging (NIA), Baltimore,

MD- subcontractor for Skanska USA, August 2007.

• United States Pharmacopoeia, October-November 2007

DESIGNATIONS:Corporate Status: LLC

Size Standard- Small Business

DUNS Number: 800612835

CAGE CODE: 4SNV7

ORCA Registered

NAICS CODES:

SIC CODES:

8744 Facilities

8711 Engineering Services

8734 Testing Labs

Capabil it ies Statement

NSF Certified Services

Clean Room/HEPA/Laminar Flow Certification

Technical Support Services

Equipment Selection, Management, Repair, and Maintenance

Lab Environmental Health and Safety

Regulatory and Training

CGMP Compliance Assessments and Audits

GxP Training

Cleanroom Environmental Monitoring Programs

USP<797> Compliance and Testing

On-site Calibration

Calibration

Facility Calibration Programs

236210 Clean room construction

325411 Medicinal and Botanical Manufacturing

325412 Pharmaceutical Preparation Manufacturing

325413 In-Vitro Diagnostic Substance Manufacturing

325414 Biological Product (except Diagnostic) Manufacturing

541330 Engineering Services

541380 Testing Laboratories

541614 Process, Physical Distribution, and Logistics Consulting Services

541690 Other Scientific and Technical Consulting Services

561210 Facilities (except computer operation) support services