Data driven pharmaceutical consultancy

grounded in process understanding, where data analysis is nothing without process context

We support pharmaceutical and biotech organizations with GMP auditing, process validation, investigation, process verification and control
- across the full product lifecycle -

What we deliver different ways of working

Support or Full Service models

We work as a full service partner or as targeted support within your team. Flexible engagement aligned to your needs and stage of development

Support

We operate through two distinct engagement models,
depending on how you need support.

1. Active team member within your project

  • Embedded within your organization or program

  • Work alongside your teams and external partners

  • Direct involvement in operational delivery and decision making

  • Maintain continuity across development, transfer, and commercial
    manufacture

2. Independent advisor reviewing decisions and data

  • External, objective review of performance and risk

  • Assessment of data integrity, trends, and conclusions

  • Challenge assumptions and confirm whether decisions are supported
    by evidence

  • Provide clear, unbiased dations

  • Due diligence teams bring strong commercial and financial expertise. They often lack deep technical capability to assess whether a product or facility is operating in a true State of Control.

    We provide this missing layer of insight through structured, data led review.

    • Assess whether process performance is consistent and predictable across time

    • Determine if the operation is in a demonstrable State of Control

    • Review CPV, OPV, and APR/PQR outputs for validity and completeness

    • Identify gaps between reported performance and actual data behavior

    • Challenge conclusions where analysis or context is incomplete

    We work from summary level down to batch level detail.

    • Drill into raw datasets, not only reported metrics

    • Separate signal from noise using appropriate statistical methods

    • Link data behavior to process design, equipment, and operational practice

    • Identify step changes, shifts, and hidden variation

    This provides a clear view of the true condition of the asset under review.

    • Confirms whether performance claims are supported by evidence

    • Quantifies risk linked to variability and control gaps

    • Supports investment, acquisition, and partner selection decisions with objective analysis

How we operate

  • Select from a network of seasoned professionals with industry and regulatory experience

  • Projects delivered across Europe, US, and international markets

  • Data analysis linked to real manufacturing conditions and decisions

  • Flexible model based on your need and stage of development

Engagement model

  1. Full service provided

  2. Embedded team support working alongside your organization

  3. Independent expert review and challenge

  4. Remote analytical and reporting support

  5. Interim roles to maintain continuity during change or growth

Full service delivery

  • Process design and development strategy

  • Process validation and Continued Process Verification

  • Investigation of deviations, OOS, and process shifts

  • Stability data analysis and shelf-life assessment

  • Due diligence based on performance, not narrative

  • Audit preparation and GAP assessment

  • Statistical training applied to real or your own datasets

  • Management of CDMO/CMO - we act as an integrated stakeholder in the management of a Contract Development and Manufacturing Organization.

    • Oversight of CDMO performance and decision making

    • Alignment of process understanding with manufacturing execution

    • Structured review of ongoing performance using OPV and CPV

    • Integration of findings into APR and PQR reporting

    This approach gives you confidence in ongoing quality and process consistency with high levels of data analysis and process context experience.

    It ensures:

    • Effective trending using appropriate statistical tools

    • Clear linkage between data signals and process context

    • Early identification of variation and emerging risk

    • Decisions supported by objective evidence rather than narrative

Direct Access to Services Provided

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Auditing

    • Use structured data analysis to support, target, and justify auditor judgement

    • Focus reviews on how processes perform, where risk sits, and where action is required

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Statistical Training

    • Training ranges from standard courses to targeted mentoring

    • Support includes development of policies and SOPs that define how statistical methods are applied in practice

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Business Due Diligence

    • Focus on data to define criticality and risk

    • Move beyond narrative by assessing how the organization performs in practice

Stability Analysis

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    • Assess stability performance within ongoing CPV and shelf-life determination

    • Apply modelling approaches alongside traditional univariate methods to support decisions

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Process Investigation

    • Most issues involve multiple linked events rather than a single cause

    • Map the chain of events using data and process knowledge to focus on the critical factors

    • Define cause and effect relationships and support clear, evidence-based conclusions.

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Process Validation

    • Structure validation activities across development, process qualification, and continued verification

    • Define sampling approaches using sound statistical principles

    • Support protocol development and report writing to demonstrate State of Control

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Best Practice Trending

    • The value of process behavior charts depends on how well they are understood and applied

    • Build clear interpretation so signals are recognized and acted on correctly

    • Link trends to CPV and Annual Product Reviews to support ongoing assessment

    • Use data to drive decisions, not assumptions

Contact Us

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