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T&M understands that time-to-market
focus, FDA cGMP requirements, systems reliability, design flexibility,
process optimization and product flexibility are critical to
a project's success. T&M thoroughly evaluates the integrity
and reliability of systems to determine if all requirements are
met to assist facilities in achieving compliance in accordance
with FDA expectations.
In the design and construction of sophisticated
facilities today, the ability to compress time-to-completion
is more critical than ever. Projects are calling for a higher
level of technological expertise. Higher yields are imperative
for both new and developing industries.
While pioneering strategies for fast-track,
design/build, regulatory and compliance, the Technology Division
has developed an unmatched ability to provide deliverables in
the early stages of projects. The Firm's goal is to help capture
and maintain a major share of the market for its clients by bringing
new, expanded or renovated facilities on-line in the shortest
possible time. T&M's solutions are cost-effective and in
compliance with the necessary controls and standards required
within the specific type of business.
The combining of consulting engineering
and technological capabilities enables T&M to respond rapidly
to unforeseen situations discovered during routine system inspections,
validation and commissioning studies. With two offices in New
Jersey and an independent affiliate in Puerto Rico, T&M is
staffed with over 200 professionals prepared to respond to the
immediate needs of its clients.
The Technology Division is staffed by experienced
software, system and engineering professionals dedicated to all
aspects of validation including computer systems, equipment,
utilities and facilities qualification. The Principals of T&M
have provided services worldwide to clients such as Schering
Plough, Warner-Lambert, Bristol-Myers, Pfizer, IPR (Astra-Zeneca)
Corporation, Baxter, Sterling Pharmaceuticals, Lederle, Novartis,
Merck and Johnson & Johnson.
T&M's areas of expertise also include:
- Manufacturing areas and validatable pilot
plants
- Facility automation and advanced process
controls
- Product finishing and packaging (tableting,
injectables and orals)
- Specialized utility systems (such as water
systems, HVAC, air systems, ect)
T&M offers the following services:
- Assessment and Auditing
- Master Planning
- Design-Build
- Engineering
- Procurement
- Project Management
- Scheduling, Estimating and Administration
- Environmental Permitting
- Front-end Packages & Commissioning
- Construction Management Support
- Validation (IQ, OQ, PQ & FR)
- Standards Operational Procedures (SOP's)
- Start-up assistance
- Engineering, Validation, Regulatory and
Compliance Consulting
T&M's Technology Division offers a
comprehensive set of consulting services. With diverse Engineering,
Technological and Auditing capabilities, T&M will deliver
the specific services required to meet the needs of each individual
client.
Our staff brings extensive collective experience
to the T&M Team. Individual members of our team have evaluated
the existing design applications, audited for regulatory compliance,
and completed validation and engineering projects for numerous
international companies.
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