Our Range of Services
PMP Certified Project Management
ETS provides PMP certified project management expertise across complex projects that carry the challenges of compressed schedules, financial discipline, technically detailed user requirements and compliance with current good manufacturing practice regulations (CGMPs).
ETS is experienced with the following models of project life cycle management and their associated deliverables:
- PMI's 5 phases of the project life cycle
- Stage-gate process for capital investments within manufacturing operations
- Stage-gate decision product development pathway
- Design/bid/build and design/build of cGMP facilities
ETS has developed the following project management deliverables for its life science clients:
- Project charter
- Risk assessment
- Risk register
- Scope document
- Budget
- Schedule
- Action items log
- Tech transfer document
ETS uses all best practice tools including earned v. planned value when reporting out to key stakeholders.
Management Consulting: Operational Improvement, Corporate Strategy & Finance
ETS integrates its engineering and management consulting expertise to uniquely deliver innovative solutions to issues as they arise during the project life cycle or in the day-to-day challenges of your operations. This service complements our PM service offerings. Together, they uniquely position ETS to deliver elegant solutions expediently across all operational verticals.
ETS has recently developed the following deliverables to its clients:
- Business plan development, including weighted average cost of capital (WACC) & net present value (NPV)
- Operational process improvement
- Site assessment of current state operations (including purified water system) resultant from mass recall due production contamination. Over 75 deficiencies were identified in one case with recommendations for improvement
- Packaging operations transition plan—roadmap of requirements to sustain productivity gains when transitioning from the capital project to normal operations
- Off balance sheet financing—Equipment lease v. buy. ETS has advised when leasing is optimal strategy. ETS even arranged favorable terms with a commercial bank on our client's behalf
Commissioning & Qualification
With over 15 years of commissioning and qualification experience, ETS has the resources to develop your qualification protocols in accordance with ASTM e2500, current risk-based guidance from FDA and EMA and in compliance with current federal regulations and their international equivalent.
Our experienced team of professionals easily align with the client's methodology towards commissioning and qualification, developing protocols in accordance with your internal procedures while bringing industry best practices to you.
ETS deliverables include:
- Design reviews and qualification
- Commissioning protocol development and execution
- Facility and process startup—in either a leadership or support role
- IQ/OQ/PQ protocol development
- ERP systems integrated commissioning and qualification in either a leadership or support role
Biopharm & Packaging Process Design
ETS has delivered process design solutions to its biopharm clients in bulk, fill/finish, lyophilization, inspection and packaging operations. We work closely with the client and listen carefully to learn from its team the requirements considered critical to its success. We capture client requirements in the development of comprehensive requirements specifications for each piece of equipment. We then integrate them in delivering a robust and cost effective process solution.
ETS takes its process expertise one step further. In partnership with the research and testing resources of two of the top engineering colleges in the US, ETS is able to provide design solutions to technical issues that arise during commercial scale up or tech transfers.
ETS identified root causes to process failures in existing biopharm processes, and then proved causality via the testing resources and expertise of its university partner.
ETS engineering services include:
- Packaging engineering/integration
- Process design and upscaling
- Risk assessments
- URS and equipment specification
- Contractor selection and management
- FAT/SAT/start-up