New Pharmaceutical Start-up
Over the past 20 plus years GPN SMEs
have been involved in numerous new facility start-ups and expansions.
In particular, we have been involved in the areas of planning and
management of projects, validation and qualification of both the
facilities and the processes, compliance and regulatory readiness and
the operational start-up of the facilities.
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Site
Selection
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GPN
has a defined and proven methodology for site selection. This is based
on the experience we have gained over the years and our knowledge of
the local environment. Our experience in this field also means that we
are in an ideal position to interface and coordinate with all the
governmental and regulatory bodies involved in this process. We have
been involved in this for a number of confidential clients. |
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Integrated Project Timelines |
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Integrated Project Timelines are a critical success factor for both
new facilities and expansions. The focus is to provide a clear plan
for facilities and operations start-up right through to product
launch. All the other project plans (design, construction, validation,
process scale-up, process validation, exhibit batches, regulatory,
etc) are integrated into one cohesive whole. Risks, problems and
conflicts are identified and solutions are proposed. GPN SMEs have
over 20 years experience in the development of integrated timelines
and what the issues that need to be resolved. This experience has been
gained in both new sites, and on expansions, and on new product and
process introductions to existing sites, in a number of countries.
GPN’s experience can add value to the project planning and management
process by looking for and delivering savings. |
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