Project Management Driven by Process Knowledge and Technology
Turn complex life science initiatives into structured, well-governed projects that deliver on time, on budget, and in full compliance. Led by project managers who understand processes, technology, and the realities of regulated operations.
































Common challenges in project management
Compliance becomes a bottleneck instead of an enabler
GxP expectations are well known, yet validation is still approached reactively. Documentation lags behind delivery, quality teams lack early visibility, and remediation work piles up late in the project. The results in timelines slip, costs rise, and launch-readiness becomes unpredictable.

Teams work in parallel rather than together
Projects often span IT, QA, manufacturing, supply chain, and external vendors. When ownership is unclear, and teams work in parallel rather than together, decisions stall, risks go unnoticed, and delivery loses momentum. Technology now starts serving individual departments rather than supporting the business as a whole.

No bandwidth to optimize while executing under pressure
Clinical operations run at full speed: managing sites, documents, monitoring, milestones, and regulatory updates. Teams know workflows could be smoother, but they lack the capacity to redesign processes, resolve data issues, or align systems while trials are active.
Optimization is postponed, inefficiencies persist, and regulatory changes add new layers of work nobody has time to address.

Manufacturing projects require interdisciplinary leadership
Greenfield and brownfield initiatives involve engineering, automation, quality, process experts, operators, and external vendors – and each discipline speaks its own language.
When no one translates the needs into right-sized requirements, the solutions become over-engineered, risks go unmanaged, and timelines drift


We solve this by
Structured delivery model
A proven framework with clear milestones, templates, and governance. Progress stays visible, and risks stay under control from initiation through go-live.
Business and technology alignment
Project leadership that connects strategy, operations, and system design. Every decision ties back to business value, not just technical feasibility.
Integrated compliance
Validation and quality activities run alongside delivery. You stay inspection-ready without slowing momentum or adding unnecessary overhead.
Vendor and stakeholder coordination
Aligned communication across vendors, internal teams, equipment owners, QA and IT. Everyone works from the same objectives, which reduces surprises and keeps projects moving.
Process-driven leadership for manufacturing projects
We translate technical input into right-sized requirements, identify risks early, and deliver manufacturing projects that meet needs without unnecessary complexity.
What effective project management looks like
Time, cost, and quality in balance
Projects deliver within agreed timelines and budgets while maintaining the compliance your business case requires.
Compliance is built into the process
Validation and documentation stay aligned with delivery, so inspection readiness becomes routine rather than a scramble.
Decisions that create business value
Technical choices support long-term scalability, operational efficiency, and quality outcomes. No over-engineering. No detours.
Stakeholders aligned around one roadmap
Clear governance keeps decision-makers connected, reduces friction, and maintains momentum from planning to go-live.
Hear from our clients
Practical results delivered through deep life science expertise.

Why life science leaders choose Epista
Project management built for life science
Project leaders who have been inside pharma and biotech operations. We know the pressures, the constraints, and what “good” looks like in practice.
Experienced project managers
Decades of hands-on delivery across ECM, ERP, QMS, serialization, and manufacturing systems. No learning curve. No guesswork.
Structured but pragmatic
Proven frameworks applied flexibly to match each organization’s maturity, culture, and operating model.
Transparent collaboration
Open communication on risks, timelines, and trade-offs. Expectations stay aligned from day one.
