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Core Engineering/Design Services
Using state-of-the-art simulation tools CDI-Life Sciences assists clients with process
scale-up, optimization studies and utilities system impact studies. In addition,
we also conduct thorough economic and production cost analyses for new facilities
and additions to existing facilities.
CDI-Life Sciences assists clients with GMP reviews of new facility design, evaluation
of existing operations, cGMP audits of facilities/suppliers and FDA regulatory consulting.
CDI-Life Sciences helps clients during the earliest phases of grass roots projects,
and during strategic shifts at existing sites through creative Master Planning studies.
We consider space programming, adjacency requirements, expandability, flexibility,
utility requirements, and aesthetics to arrive at optimal site and facility configurations.
In addition, CDI-Life Sciences performs traffic studies, survey and incorporate
local permitting and zoning requirements, provides master plans that comply with
state and local codes, and presents those plans to local authorities on behalf of
clients.
CDI-Life Sciences has expertise to analyze available infrastructure and match it
with facilities requirements. Analysis encompasses facility requirements, economics,
tax structures, cost and availability of labor, cost of construction, accessibility,
logistics and distribution channels. In addition, we have the expertise to negotiate
incentives from state and local governments on behalf of clients.
CDI-Life Sciences is frequently contracted to perform process and facilities design
sufficient to establish an appropriations grade cost estimate and overall project
schedule.
CDI-Life Sciences work processes include the use of smart tools and intelligent
P&IDs that are integrated with equipment lists, datasheets and specifications. We
have expertise with industry-specific unit operations, high purity piping systems,
and state-of-the-art process automation and controls.
CDI-Life Sciences provides a full range of facility design services, including architecture,
civil, structural, HVAC, plumbing, fire protection and electrical for state-of-the-art
cGMP facilities. Our philosophy is that facility design is fully integrated with
the process design through all the phases of the project.
CDI-Life Sciences provides services for vendor and subcontractor qualification,
bid preparation and analysis, and terms negotiation in the procurement of GMP equipment
and services.
CDI-Life Sciences has experienced professionals trained in construction practices
required for GMP facilities and pharmaceutical clean room construction. We provide
pre-construction services, site management, planning, cost control, value engineering,
and quality assurance functions.
CDI-Life Sciences develops, plans and executes protocols for commissioning for GMP
and non-GMP pharmaceutical industry facilities. We have current experience with
implementation of ISPE Commissioning Baseline guide recommendations.
CDI-Life Sciences develops validation master plans, plan and schedule validation
projects, writes SOP's, and prepares and executes IQ, OQ, and PQ protocols. In addition,
CDI-Life Sciences also provides GMP training and certification and pre-FDA plant
inspections. We have developed and proven a methodology for efficient integration
of commissioning and validation activities in accordance with ISPE guidelines.
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