Engineering solutions for global life science...
Transcript of Engineering solutions for global life science...
Engineering solutions for global life science companies
3000 Hunters Bluff Drive
Raleigh, NC 27606 USA
Tel 919-696-7397
mentortg.com
Tailoring solutions for Biotechnology, Pharmaceuticals and Medical Devices
O U R S O L U T I O N S
C A L I B R A T I O N
Our calibration professionals are highly proficient in calibration
performance on all test and critical process instruments.
U T I L I T I E S
Our experienced utilities personnel can run your day-to-day
maintenance operations, freeing your people to concentrate on
strategic objectives.
C O M P L I A N C E , C & Q
Our compliance and C&Q experts are the perfect solution to your
Performance Validation and Commissioning & Qualification needs.
E H S
Our rigorous Safety and Environmental Project Coordinators (SEPCs)
can assist you in developing and implementing effective corporate
safety programs.
S E R V I C E - O N - D E M A N D
Our on–demand specialists can provide a broad spectrum of
mechanical services, from HVAC installations to fleet vehicles
maintenance and much more in between.
A global leader in life science engineering and
technical solutions, we at Mentor Technical Group
have the knowledge and experience with FDA
and international agencies to ensure compliance
with pharmaceutical, biotechnology, and medical
device safety and efficacy guidelines. Our
products are vertically–integrated and aligned to
meet our clients’ unique and changing business
requirements and achieve their individual goals.
With a talent pool of more than 500 trained life
science professionals, we can reliably and cost–
effectively manage all engineering, quality, and
cost savings challenges your company might
encounter.
E N V I R O N M E N T A L H E A L T H A N D S A F E T Y
C A L I B R A T I O N
R E G U L A T O R Y C O M P L I A N C E
T H E P R O C E S S
Single-Source Solut ion
Our global vertically–integrated value–
chain provides clients with options for all
of their technical, support, and manage-
ment solutions. Our goal is to improve
process efficiency and achieve objectives
with minimum risk. Mentor Technical
Group has earned a reputation as a
“preferred service provider” with many of
the world’s most successful life science
companies.
Project Gap Analys is
Today’s regulatory and technology–driven
environment requires companies to per-
form gap analysis continuously to identify
specialized resources to achieve their
project objectives. We have the resident
knowledge and experience and available
resources to deliver solutions within the
client’s budget and schedule.
Performance Management
The cornerstone of our success is
Performance Management. Employing
risk–based solutions and best–business
practices, we continuously monitor
upstream outputs to control downstream
input results. Functions that could impact
on preferred solutions are identified, ana-
lyzed, and revised early in the process.
Cost Savings
Utilizing project management software
solutions (PMSS) and value–engineering
models, Mentor Technical Group achieves
our clients’ Continuous Improvement
Programs (CIPs) objectives. Pre–deter-
mined solutions for process efficiency,
quality, and cost savings are documented,
monitored, and controlled for each
assignment.
Experts Who Del iver
Structured as a matrix–managed com-
pany, our core team of Business Unit
Managers and Subject Material Experts
(SMEs) possesses the expertise required
to propose effective, tailored solutions
that deliver the highest standard of per-
formance at the lowest possible cost. We
continuously monitor processes to ensure
the client’s expectations are achieved.
Tailoring solutions for Biotechnology, Pharmaceuticals and Medical Devices
C L I E N T S Allergan
AstraZeneca
GlasxoSmithKline
Bristol–Myers Squibb
Lilly
Medtronic
Merck
Abbott Laboratories
Watson
Sanofi Aventis
Johnson & Johnson
Roche
Novartis
Bausch & Lomb
Cardinal Health
Baxter
S E R V I C E - O N - D E M A N D
U T I L I T I E S
3000 Hunters Bluff Drive
Raleigh, NC 27606 USA
Tel 919-696-7397
Alhambra Granada Blvd.
Caguas Real
Caguas, PR 00725
Tel 787-743-0987
811 Town & Country Blvd
Houston, TX 77024
Tel 787-649-8207
C A L I B R A T I O N • On–site Calibration & Certification
Services• On–site Instrumentation Technician• Calibration Program (Scheduling
Maintain)• Equipment Rental (Data Loggers,
Recorders) • Analysis and Optimization (Frequency,
Accuracy, Performance, and Criticality) • Temperature Mapping • Calibration Program Management
and Calibration Standard Operating
Procedures (SOP) Generation
U T I L I T I E S• Technicians and operators for specific
tasks • Technical Support• Training and support to critical and
non–critical utilities personnel• Continuous improvement support to
identify efficiency• Regulatory Support• Turn–Key Solutions
S E R V I C E - O N - D E M A N D• HVAC Installations & Maintenance• Refrigeration Maintenance• Lift Trucks Maintenance• Electrical Systems Maintenance• Infrared Analysis• Ultrasound Analysis• Vibration Analysis• Laser Alignment• On–site Dynamic Balance• Standby Generators Maintenance• Motors, Pumps & Mechanical Seals• Welding & Fabrication• Tool & Die• Fleet Vehicles Maintenance• Outsourcing: Mechanical
C O M P L I A N C E• Validation Services• Validation Project Management• Quality/Validation Master Plans• Quality Risk Assessment• Facilities & Utilities C&Q/Verification• Process and Packaging Equipment
C&Q/Verification • CSV• Process Validation/Re–validation• Cleaning Validation• Packaging Validation• Laboratory Equipment Validation• Decommissioning• Regulatory Compliance Services
C A P A• Annual Reviews• Assessment & Remediation• Product Transfer Strategy, Coordination,
and Implementation• Technical Services• Technical Services Master Planning• Process Optimization/Cost Reduction• Process and Product Transfer• Packaging Technology Transfer• Process Characterization• Process Development
E H S• Safety and Environmental Trainings• Forklift, Aerial Lifts Trainings
Certifications• Confined Space Entry Equipment Rental• Safety Inspections• Industrial Hygiene Services• EHS Assessments• EHS Services• Environmental Technicians• Industrial Hygiene Specialists• EHS Specialists• Safety Officers• EHS Coordinators• Safety Inspectors for Construction
Projects• Safety Officers• Regulatory Support• Turn–Key Solutions
mentortg.com
Proven Performance Value