Much Success in 2012
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What we
deliver |
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G.P.B.
Limited delivers Compliance Solutions for Regulatory
Affairs (RA) and Quality Assurance (QA)
providing consulting, training and outsourcing services
to the medical devices & biologics sector. Our
experienced team provide expert, efficient
compliance support services including advices, hands-on
support and complete management services.
We work with:
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Clinicians, inventors, research
establishments, universities, who wish to
complete Proof of Concept and define potential
regulatory paths.
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Designers
and specification developers to identify
standards and regulatory aspects pertinent to
their device(s) and implement effective
product development controls to meet
regulation.
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Manufacturers,
packagers and distributors who wish to market
new and/or change their medical devices or
market in a new geographical location.
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Our clients' sub-contractors,
device inventors, licensors, licensees,
designers, prototypers and manufacturers to develop and
implement effective systems of control to meet
contractual and regulatory requirements for
global market clearance.
We are aware of the drivers to reduce the time
from concept to delivery of the device to
market. Accordingly we work with our Clients
to plan and implement effective, efficient
strategies from concept, specification, design, development, design
transfer, manufacturing and distribution of
their devices.
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NEWS: Clarity in Regulatory
Affairs
 We
have launched a secure on-line document
management service for all new clients via the new
www.gpb.biz portal. These dedicated
confidential Client sites
offers our clients access to useful links, reference materials,
discussion forums, libraries, helpdesk, presentation and
training materials.
The document management portal also contains
the Client's design & development plans, Technical File, design, test and
manufacturing protocols ,test results and quality system(s)
documentation.
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Consultancy |
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Working
closely with and assisting our clients attain and maintain the
necessary regulatory approvals to market their devices world
wide.
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Outsourcing |
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Providing
hands-on executive and managerial RA & QA support and expertise
to our Clients. Acting as our clients' internal compliance RA and QA
resource to assist in product development, clinical assessment and regulatory
clearance.
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Training |
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Delivering
practical workshops and training courses to meet agreed objectives and
defined outcomes.
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