Selecting processes that fit your needs and determining the optimal equipment configuration
Accurate cost estimates based on our track record and experience
Proposals to optimize running costs
Reviewing packaging formats, automation and labor saving, and environmental measures
Reviewing utilities, and procurement, storage, warehousing and distribution
Planning the business schedule
Setting the business budget
Owner's Challenges
Owner's Challenges
The business concept needs to be organized into equipment requirements
Proposed Programs
Proposed Programs
Through interviews with the owner, we organize the conditions needed for basic design.
We propose facility and equipment specifications that meet the latest GMP requirements.
02
Basic Planning
Project Activities
Project Activities
1Basic Planning Support
Developing a basic plan that looks ahead from R&D to sales
Basic plan design and organizing conditions for basic design
Preparing the user requirements specification (UR)
Preparing the development plan
Preparing the validation master plan
Reviewing optimal cost and lead time
Developing the budget estimate and project schedule
Owner's Challenges
Owner's Challenges
Unsure how to organize the requirements needed to design facilities and equipment
Not up to date with the latest GMP requirements
Not enough in-house resources to prepare the UR
Proposed Programs
Proposed Programs
We organize the owner's requirements and draft the UR.
We propose facility and equipment specifications that meet the latest GMP requirements.
Following your business plan, we support preparation of the basic plan from R&D to sales, the requirements specification, the development plan and the validation master plan.
03
Design Vendor Selection
Project Activities
Project Activities
3FEED for EPC Bidding
Confirming the technical issues and rough costs identified in FEED
Preparing EPC bidding and vendor selection specifications
Listing candidate vendors
Evaluating proposals and quotations
Selecting the vendor
Owner's Challenges
Owner's Challenges
Not enough in-house resources to prepare selection specifications
No experience evaluating proposals and quotations
Proposed Programs
Proposed Programs
We support preparation of vendor selection specifications that reflect the FEED results.
We support evaluation of the proposals and quotations submitted by vendors.
04
Basic Design
FEED / BASIC DESIGNFEED (Front End Engineering Design) is the basic design carried out after conceptual design and the FS. At this stage, before EPC (engineering, procurement and construction), technical issues and rough costs are examined through design. We drive this work together with the owner.
Project Activities
Project Activities
3FEED for EPC Bidding
Reflecting conceptual design and FS results in the basic design
Examining technical issues and rough costs through design
Preparing draft URS and VMP
Defining outline specifications for facilities, equipment and systems
Preparing the basic design document
Reviewing the budget and schedule
Owner's Challenges
Owner's Challenges
Shortage of engineering staff to act as the point of contact with vendors
Not enough in-house resources to draft the URS and VMP
Proposed Programs
Proposed Programs
As owner's consultant, we attend meetings and facilitate discussions with vendors.
We organize technical issues and rough costs and support a basic design that leads to EPC bidding.
We draft validation documents such as the URS and VMP.
05
Detailed Design
Project Activities
Project Activities
4Engineering Support Services
Project management in the detailed design phase
DQ based on the URS
Reviewing specifications and design documents
Scrutinizing procurement specifications and quotations
Budget and schedule management
Planning the preparation of validation documents
Owner's Challenges
Owner's Challenges
Not enough in-house resources to perform DQ
No experience reviewing quotations
Proposed Programs
Proposed Programs
As owner's consultant, we attend meetings with vendors and facilitate discussions.
We draft validation documents such as the URS and VMP.
On the owner's behalf, we review design documents and specifications against the URS and perform DQ.
We support quotation review (with partner consultants).
We support project management in the detailed design phase in line with GMP.
06
Fabrication, Construction & Inspection
Project Activities
Project Activities
4Engineering Support Services
Project management in the procurement and construction phase
Fabrication, construction and installation based on specifications
FAT, SAT, acceptance inspection and IQ
Reviewing validation documents and supporting execution
Liaison with authorities
Owner's Challenges
Owner's Challenges
Management of the construction phase is left to vendors
Shortage of staff to witness acceptance inspections and review related documents
Proposed Programs
Proposed Programs
On the owner's behalf, we oversee construction progress and liaison with authorities (with partner consultants).
We review FAT, SAT and IQ documents and witness tests as needed.
We support project management in the procurement and construction phase in line with GMP.
07
Commissioning & Inspection
Project Activities
Project Activities
4Engineering Support Services
Project management in the commissioning phase
Commissioning & Inspection
OQ work and qualification
Preparing and executing validation documents
Preparing the validation report
Owner's Challenges
Owner's Challenges
Not enough in-house resources to review OQ documents
Proposed Programs
Proposed Programs
We review the full set of OQ documents prepared and executed by vendors.
We support the owner's practical work from commissioning through completion of qualification.
We support project management in the commissioning phase, and validation documents from preparation through execution, in line with GMP.
In addition to GxP consulting for pharmaceuticals, APIs, quasi-drugs and medical devices, we provide owner-side engineering services across a wide range of projects, including new businesses, new products and renovations, working with construction companies, engineering firms, equipment manufacturers and others.
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