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OPERATIONAL READINESS

Interested in seeing what we can do for you? Call or email us to start the conversation.
Cell and gene therapy research facility operational readiness man in lab suit looking through microscope example image.
Facility Operational Readiness

For facilities and laboratories (Green Field, expansion, retro-fit, as well as companies that outsource services in MFG, Supply Chain, Clinical Trials)  Dahlia will partner and drive the integrated elements to prepare the facility and laboratory to operate according to the applicable regulations.

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Governance Design and Management

Together with the client, Dahlia will assist in the formulation of the project team and develop accountability structure to ensure decisions are made properly.​

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Biotech pharma governance design and managment chain of command graphic image example.
Cell and gene therapy research integrated project
Integrated Project Planning and Scheduling

As part of the initial strategic discussions, schedule scenarios will be presented. Pending the final decision of the business operation plan, Dahlia will manage the project to the approved and final schedule baseline.

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Cost, Budgeting, Forecasting and Modeling

Partner with the client to develop all budgetary baselines, including materials, equipment, testing, consultants/contractors and other outside services.
Cell and Gene Therapy consultants hands pointing to important pharmaceutical points image example.
Gene and Cell Therapy research Facility & Laboratory Equipment graphic image example.
Facility and Laboratory Equipment
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Dahlia will partner with the client to establish business process to procure and qualify equipment as required to meet with budget and timelines.

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Tech Transfer

Dahlia will partner with the client to develop timelines for technology, process or system transfer and integrate into the overall project plan.

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Pharmaceutical the transfer of technical assets image of person looking through microscope image example.
Environmental Monitoring Performance Qualification for cell and gene therapy therapy research and project planning image of bio petri dish
EMPQ
(Environmental Monitoring Performance Qualification)

Dahlia will partner with the client to prepare protocols, schedules and integrate into the overall project plan.

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Engineering Runs

Developing specifications, demonstrating manufacturing process steps or identifying and resolving any potential issues before formal cGMP (current Good Manufacturing Practice) documentation and activities.

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cGMP current good manufacturing practice during engineering runs and cell and gene therapy development image of lab techs working.
Cell and gene therapy discovery documentation transfer graphic image example.
Document Transfer

Process of enabling, sharing, transferring or transmitting files and data between different users both locally and remotely.

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Dahlia Pharma Biotherapeutics Advisors Science

OPERATIONAL READINESS

Interested in seeing what we can do for you? Call or email us to start the conversation.
Cell and gene therapy research facility operational readiness man in lab suit looking through microscope example image.
Facility Operational Readiness
For facilities and laboratories (Green Field, expansion, retro-fit, as well as companies that outsource services in MFG, Supply Chain, Clinic Trials)  Dahlia will partner and drive the integrated elements to prepare the facility and laboratory to operate according to the applicable regulations.

LEARN MORE
Biotech pharma governance design and managment chain of command graphic image example.
Governance Design and Management
Together with Client, Dahlia will assist in the formulation of the project team and develop accountability structure to ensure decisions are made properly.​

LEARN MORE
Cell and gene therapy research integrated project
Integrated Project Planning and Scheduling
As part of the initial strategic discussions, schedule scenarios will be presented. Pending the final decision of the business operation plan, Dahlia will manage the project to the approved and final schedule baseline.

LEARN MORE
Cell and Gene Therapy consultants hands pointing to important pharmaceutical points image example.
Cost, Budgeting, Forecasting and Modeling
Partner with client to develop all budgetary baselines, including materials, equipment, testing, consultants/contractors and other outside services.
Gene and Cell Therapy research Facility & Laboratory Equipment graphic image example.
Facility and Laboratory Equipment

Dahlia will partner with client to establish business process to procure and qualify equipment as required to meet with budget and timelines.

LEARN MORE
Pharmaceutical the transfer of technical assets image of person looking through microscope image example.
Tech Transfer
Dahlia will partner with client to develop timelines for technology, process or system transfer and integrate into the overall project plan.

LEARN MORE
Environmental Monitoring Performance Qualification for cell and gene therapy therapy research and project planning image of bio petri dish
EMPQ
(Environmental Monitoring Performance Qualification)

The construction process includes not only the buildout of the space itself, but also the integration of all the elements within it such as technology, furniture, equipment. Dahlia will integrate all elements into its purview. Each element will be reported upon via executive summary document provided weekly which includes minutes, current tracking logs, photos.​

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cGMP current good manufacturing practice during engineering runs and cell and gene therapy development image of lab techs working.
Engineering Runs
Developing specifications, demonstrating manufacturing process steps or identifying and resolving any potential issues before formal cGMP (current Good Manufacturing Practice) documentation and activities.

LEARN MORE
Cell and gene therapy discovery documentation transfer graphic image example.
Document Transfer
Process of enabling, sharing, transferring or transmitting files and data between different users both locally and remotely.

LEARN MORE
Dahlia Pharma Biotherapeutics Advisors Science

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