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Experienced Validation
Professionals |
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Flexible, practical
solutions |
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Knowledgeable, dedicated
staff |
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Strong equipment
supplier relationships promoting improved project
performance |
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Extensive equipment
design experience |
SMB Group Inc. serves three
major markets: The Pharmaceutical, Medical Device and
Biotechnology manufacturers or PMDB industry and the Equipment
Designers and Builders that are suppliers to the PMDB
industry.
Additionally, training opportunities
exist for those individuals who wish to enter or stay current
within the PMDB industry. The primary target market
encompasses all PMDB Manufacturers and their immediate
subsidiaries that are subjected to FDA and other similar
regulations as well as some of their major direct suppliers.
Laws & Regulations in this targeted market are becoming
more and more stringent and will result in the compliance
functional units of PMDB manufacturers having to meet
ever-increasing requirements.
The services of SMB Group Inc.. are based on
USFDA regulations. Many PMDB Manufacturers wish to apply a
consistent standard to all their installations regardless of
their actual geographical locations. The FDA regulations being
generally recognised as the most exacting in the world, they
are frequently selected as the reference standard. Moreover,
with continued development of new biotechnologies, the target
market is continuously expanding. New Biotech companies are
continually created. Most Biotech companies are purposely
maintained as relatively small business entities in order to
minimise the risk in the event of a catastrophic adverse event
that could literally “sink” the company. Because of their
relatively small scale, many of these, if not most, are not
staffed with all the traditional disciplines.
The second target market for
SMB Group Inc. consists of the
numerous Equipment Designers/Manufacturers and Distributors
that are suppliers to the PMDB industry. With the shrinking of
internal support staff within the PMDB industry, the industry
is turning to the Equipment Designers and Builders to provide
more extensive documentation than has traditionally been the
case. Requests for quotation from PMDB customers now typically
include requirements to provide Detailed Design Specifications
as well as other similar support documentation. Most Equipment
Manufacturers are ill prepared to deal with such requirements
and risk not being seriously considered by the PMDB
manufacturers when they seek production and packaging
machinery. The third strategic market targeted by SMB Group Inc. consists of
providing training programs for individuals who wish to enter
the PMDB manufacturers market or who wish to further develop
their knowledge of the PMDB industry and, as mentioned above,
for the personnel employed by equipment manufacturers and
distributors.
SMB Group Inc. provides cGMP
training for the engineers, designers and sales
representatives of equipment manufacturers. Adequate cGMP
training will enable the engineers and designers to better
understand the requirements of their customers and thus
provide equipment better suited to these needs. Similarly, the
equipment distributors’ sales representatives can benefit from
this type of training and hold more productive discussions
with their customers by being able to “speak the same
language”.
For more information, speak to
main expert or to send info, please use Contact us page
at the bottom or top side of this page.
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Auditing
Services |
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Quality
Plans |
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Validation Master
Plans |
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IQ, OQ, PQ
Protocol |
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Generation &
Implementation |
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Summary
Reports |
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Computer System
Validation |
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GAMP4 |
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Project
Management |
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SAT/FAT Generation &
Implementation |
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SOP Development &
Review |
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Equipment/Process
Specification |
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URS
Generation |
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FRS
Generation |
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DDS
Generation |
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