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Regulatory and Assurance
Situation: Restart blocked by regulator findings and missing evidence
Mandate and scope: Build findings register run readiness reviews and produce a regulator credible documentary set
Plan and coalition: Owners matrix independent assessors legal and quality working to one playbook
Outcome and time to value: Approval granted in four weeks and controlled restart achieved
Transmission upgrade consent and programme assurance
Description
Transmission upgrade consent and programme assurance
A transmission owner needed development consent and habitats assessment for a line upgrade while keeping security of supply. We curated planning counsel, environmental specialists and an independent programme assurance lead.
Blocker
Complex consent pathway with potential challenge risk, land access issues and tight outage windows.
Mandate
Deliver a regulator ready consent strategy, complete environmental assessments and run independent programme assurance to protect schedule and cost.
What we did
Mapped consenting route and stakeholders, aligned land rights strategy and engagement plan.
Introduced planning and environmental advisers to prepare evidence based submissions and a habitats regulations assessment.
Set up programme governance with stage gates, risk registers and independent assurance reports for the board.
Coordinated mitigation and construction method statements to satisfy conditions.
Outcome
Consent granted with manageable conditions, land agreements executed and the upgrade delivered within the outage window. Independent assurance noted on time, on budget performance.
Keywords
regulatory assurance, development consent, habitats assessment, regulator ready plan, independent assurance, programme governance, land rights strategy, stakeholder engagement, transmission upgrade compliance, evidence based submissions
Transmission upgrade consent and programme assurance
A transmission owner needed development consent and habitats assessment for a line upgrade while keeping security of supply. We curated planning counsel, environmental specialists and an independent programme assurance lead.
Blocker
Complex consent pathway with potential challenge risk, land access issues and tight outage windows.
Mandate
Deliver a regulator ready consent strategy, complete environmental assessments and run independent programme assurance to protect schedule and cost.
What we did
Mapped consenting route and stakeholders, aligned land rights strategy and engagement plan.
Introduced planning and environmental advisers to prepare evidence based submissions and a habitats regulations assessment.
Set up programme governance with stage gates, risk registers and independent assurance reports for the board.
Coordinated mitigation and construction method statements to satisfy conditions.
Outcome
Consent granted with manageable conditions, land agreements executed and the upgrade delivered within the outage window. Independent assurance noted on time, on budget performance.
Keywords
regulatory assurance, development consent, habitats assessment, regulator ready plan, independent assurance, programme governance, land rights strategy, stakeholder engagement, transmission upgrade compliance, evidence based submissions


Hydrogen production permits and safety case
Description
A green hydrogen developer needed Title V air permits and a credible process safety case to reach final investment decision. We introduced specialist permitting counsel and safety engineers and provided independent assurance on the dossier.
Blocker
Unclear permitting path for electrolyser and compression systems, community concerns and the need for a bankable safety case.
Mandate
Secure required air permits, deliver a regulator ready process safety file and align with investors and offtakers.
What we did
Introduced air permitting specialists and process safety experts with electrolyser experience.
Built an approvals roadmap, schedule and evidence list for submissions to state regulators.
Coordinated hazard studies and consequence analysis and embedded findings into design controls.
Worked with a regulated partner for any capital introductions while we remained the introducer and curator.
Outcome
Permits granted with clear operating conditions, safety case accepted by counterparties and offtake negotiations advanced. Project moved to final investment decision on schedule.
Keywords
regulatory approvals, air permits, Title V, process safety management, independent assurance, regulator ready dossier, hydrogen compliance, offtake alignment, investor readiness, approvals roadmap
A green hydrogen developer needed Title V air permits and a credible process safety case to reach final investment decision. We introduced specialist permitting counsel and safety engineers and provided independent assurance on the dossier.
Blocker
Unclear permitting path for electrolyser and compression systems, community concerns and the need for a bankable safety case.
Mandate
Secure required air permits, deliver a regulator ready process safety file and align with investors and offtakers.
What we did
Introduced air permitting specialists and process safety experts with electrolyser experience.
Built an approvals roadmap, schedule and evidence list for submissions to state regulators.
Coordinated hazard studies and consequence analysis and embedded findings into design controls.
Worked with a regulated partner for any capital introductions while we remained the introducer and curator.
Outcome
Permits granted with clear operating conditions, safety case accepted by counterparties and offtake negotiations advanced. Project moved to final investment decision on schedule.
Keywords
regulatory approvals, air permits, Title V, process safety management, independent assurance, regulator ready dossier, hydrogen compliance, offtake alignment, investor readiness, approvals roadmap


Data centre campus approvals and assurance
Description
A hyperscale data centre campus required environmental impact assessment, noise and water permits with strong stakeholder alignment. We coordinated specialists and produced an assurance path that kept the build schedule intact.
Blocker
Complex permit stack, EIA screening risk, water abstraction limits and community concerns about noise and traffic.
Mandate
Deliver a regulator ready approvals strategy, complete studies, and secure decisions from the relevant authorities on time.
What we did
Mapped decision makers across planning, environment and utilities with a clear approvals matrix.
Introduced EIA practitioners, acoustic and hydrology consultants and a community engagement firm.
Built evidence based submissions with mitigation measures and a compliance monitoring plan.
Provided independent assurance on modelling, assumptions and construction controls.
Outcome
Planning permission confirmed with conditions, water and discharge permits granted, and a monitored compliance plan accepted by authorities. Construction proceeded to the agreed timeline.
Our role was to act as an introducer and curator alongside the client and contracted providers. Delivery and legal responsibility remained with the project owner and counterparties. Details are anonymised and simplified for privacy. Fuller references are available under NDA. For any capital related elements we worked via or alongside regulated firms. We did not arrange or advise on investments.
Keywords
environmental impact assessment, stakeholder and permits, regulatory approvals, independent assurance, regulator ready submissions, noise assessment, water permits, utility alignment, data centre compliance, approvals strategy
A hyperscale data centre campus required environmental impact assessment, noise and water permits with strong stakeholder alignment. We coordinated specialists and produced an assurance path that kept the build schedule intact.
Blocker
Complex permit stack, EIA screening risk, water abstraction limits and community concerns about noise and traffic.
Mandate
Deliver a regulator ready approvals strategy, complete studies, and secure decisions from the relevant authorities on time.
What we did
Mapped decision makers across planning, environment and utilities with a clear approvals matrix.
Introduced EIA practitioners, acoustic and hydrology consultants and a community engagement firm.
Built evidence based submissions with mitigation measures and a compliance monitoring plan.
Provided independent assurance on modelling, assumptions and construction controls.
Outcome
Planning permission confirmed with conditions, water and discharge permits granted, and a monitored compliance plan accepted by authorities. Construction proceeded to the agreed timeline.
Our role was to act as an introducer and curator alongside the client and contracted providers. Delivery and legal responsibility remained with the project owner and counterparties. Details are anonymised and simplified for privacy. Fuller references are available under NDA. For any capital related elements we worked via or alongside regulated firms. We did not arrange or advise on investments.
Keywords
environmental impact assessment, stakeholder and permits, regulatory approvals, independent assurance, regulator ready submissions, noise assessment, water permits, utility alignment, data centre compliance, approvals strategy


Biologics audit readiness and independent assurance
Description
A biologics site needed a regulator ready plan to address inspection findings and restart sterile operations. Global Coalition acted as introducer and curator to assemble a quality and validation team and deliver independent assurance.
Blocker
Observations on aseptic practice, data integrity and deviation management created risk to batch release and licence conditions.
Mandate
Produce an evidence based remediation plan, align with EU good manufacturing practice and prepare for EMA and national inspectorate audit within six months.
What we did
Curated a senior quality lead, digital validation experts and a former inspector for independent assurance.
Ran a triage of critical lines, built a risk ranked remediation plan and closed gaps in training and documentation.
Implemented electronic validation and controlled document workflows with audit trails.
Prepared regulator ready submissions and hosted mock inspections.
Outcome
Partial restart achieved in four months, full capacity by month six. Inspection closed with commitments tracked under programme governance.
Keywords
regulatory assurance, regulator ready plan, independent assurance, evidence based remediation, GxP compliance, data integrity, audit readiness, EMA inspection, quality triage, programme governance
A biologics site needed a regulator ready plan to address inspection findings and restart sterile operations. Global Coalition acted as introducer and curator to assemble a quality and validation team and deliver independent assurance.
Blocker
Observations on aseptic practice, data integrity and deviation management created risk to batch release and licence conditions.
Mandate
Produce an evidence based remediation plan, align with EU good manufacturing practice and prepare for EMA and national inspectorate audit within six months.
What we did
Curated a senior quality lead, digital validation experts and a former inspector for independent assurance.
Ran a triage of critical lines, built a risk ranked remediation plan and closed gaps in training and documentation.
Implemented electronic validation and controlled document workflows with audit trails.
Prepared regulator ready submissions and hosted mock inspections.
Outcome
Partial restart achieved in four months, full capacity by month six. Inspection closed with commitments tracked under programme governance.
Keywords
regulatory assurance, regulator ready plan, independent assurance, evidence based remediation, GxP compliance, data integrity, audit readiness, EMA inspection, quality triage, programme governance


Lithium operation restart with permits and community alignment
Description
Lithium operation restart with permits and community alignment
A brine extraction and processing project paused operations due to community concerns and environmental compliance questions. We aligned stakeholders, technical consultants and offtake counterparties.
Blocker
Community consent risk, environmental baseline disputes, and buyer confidence erosion.
Mandate
Stabilise the social licence, refresh baseline studies, re secure offtake.
What we did
Introduced a local stakeholder engagement firm and an environmental consultancy with region specific experience.
Coordinated updated studies and transparent reporting.
Re engaged offtake buyers with independent assurance on compliance and schedule.
Outcome
Operating permit confirmed, staged restart approved, revised offtake with price floors.
Our role was to act as an introducer and curator alongside the client and contracted providers. Delivery and legal responsibility remained with the project owner and counterparties. Details are anonymised and simplified for privacy. Fuller references are available under NDA. For any capital related elements we worked via or alongside regulated firms. We did not arrange or advise on investments.
Keywords
stakeholder and permits, community engagement, environmental approvals, offtake, mining restart, mandate led introductions, independent assurance
Lithium operation restart with permits and community alignment
A brine extraction and processing project paused operations due to community concerns and environmental compliance questions. We aligned stakeholders, technical consultants and offtake counterparties.
Blocker
Community consent risk, environmental baseline disputes, and buyer confidence erosion.
Mandate
Stabilise the social licence, refresh baseline studies, re secure offtake.
What we did
Introduced a local stakeholder engagement firm and an environmental consultancy with region specific experience.
Coordinated updated studies and transparent reporting.
Re engaged offtake buyers with independent assurance on compliance and schedule.
Outcome
Operating permit confirmed, staged restart approved, revised offtake with price floors.
Our role was to act as an introducer and curator alongside the client and contracted providers. Delivery and legal responsibility remained with the project owner and counterparties. Details are anonymised and simplified for privacy. Fuller references are available under NDA. For any capital related elements we worked via or alongside regulated firms. We did not arrange or advise on investments.
Keywords
stakeholder and permits, community engagement, environmental approvals, offtake, mining restart, mandate led introductions, independent assurance


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