Set the governance
Assess applicable requirements, operating activities and decision authority. Clarify regulatory, quality, safety and operational responsibilities; identify gaps in the control framework and agree priorities.
Regulatory governance
Regulatory affairs consultancy.
Clear governance through delivery.
IAE provides independent pharmaceutical regulatory consulting, connecting regulatory strategy with quality and GxP governance, provider oversight and implementation. A focused review, defined workstream or fractional regulatory leadership can make responsibilities, evidence and next decisions clear. Formal sponsor, licence-holder and authorised-person responsibilities remain with the appropriate parties.
Discuss regulatory support
Strategy connected to implementation
The decision
Who owns the decision, and what supports it?
A supplier reports that everything is on track. A new service is ready to launch. A programme changes country, storage provider or operating model. The work may look contained, while responsibility and risk move across several organisations.
A well-written contract or procedure cannot resolve an untested handover. The commissioning team needs to understand the scope, the interfaces and the evidence required before accepting the arrangement.
IAE provides senior regulatory leadership and an independent assessment of the delivery model. The work turns requirements into explicit decisions, usable controls and a practical plan for follow-through.
What IAE brings to the work.
A connected assessment, a clear recommendation and support for the work that follows.
Strengthen provider oversight
Challenge proposals and scopes, examine capability and interfaces, define acceptance criteria and establish useful review and escalation arrangements. Support sponsor teams and providers in resolving gaps between their responsibilities.
Lead implementation and change
Support service development, procedures, training, remediation and programme transitions. Bring senior input to recurring decisions through a defined workstream or fractional regulatory leadership.
Work your team can use.
The exact deliverables are agreed for the assignment. Typical outputs include:
A regulatory and import-route assessment
Country, product, site and activity requirements; licence scope, import or notification questions, responsible parties and evidence needed before implementation.
An oversight model
Scope, evidence expectations, review points, escalation and accountable decisions across partners.
A controlled implementation plan
Actions, owners, dependencies and acceptance criteria for launch, remediation or transition.
Check the route before implementation
Review the proposed country route, product classification, supplier authorisations and import requirements together. An existing supplier relationship or trial-supply approval is not a substitute for checking the proposed access activity. Confirm release, labelling, safety and quality responsibilities with the relevant licence holders and authorised people.
IAE provides the assessment and defined implementation support. Regulatory submissions and formal approvals remain with the responsible sponsor, marketing authorisation holder, importer or other designated party.
Control the source, translation and approval
Application packs, labels and supporting documents need a controlled source version. Agree the translation workflow, linguistic and local regulatory reviewers, approval roles and submission responsibility before use. Keep approved versions, decisions and change history in the sponsor’s designated repository.
Assess a translation platform or document-system connection only where needed. Confirm licences, configuration, confidentiality and translation or patient-reported instrument rights. Translation does not itself confer regulatory approval, and a proposed connection is not a verified operating integration.
Provider oversight
Commission well. Stay in control.
For a small biotech or a medical affairs or clinical operations team, outsourcing can bring capability the organisation does not hold in-house. It also creates a need for informed commissioning and oversight.
IAE reviews the proposed scope, assumptions and division of responsibilities; defines what evidence the sponsor needs from its partners; and supports decisions about readiness, performance and change. Providers can also engage IAE to strengthen their service model and the governance behind it.
Supply & transitions
A change in delivery changes the assessment.
A new country, warehouse or provider can affect licence scope, import arrangements, product status, quality agreements and continuity. IAE brings those implications into the transition plan before implementation.
The work connects the proposed activity with the responsible licence holders, quality functions and authorised people. It supports a controlled handover with explicit readiness decisions.
Governance is part of access and evidence delivery. Supply, quality, safety, data and vendor work are assessed in that programme context, with specialist contributions agreed where needed.
Advice and implementation support do not replace the formal responsibilities of sponsors, healthcare professionals, quality functions, licence holders or authorised persons. Those responsibilities are made explicit in the assignment.
A clearer view of the next decision.
Bring the decision. We will shape the work.
Share the situation, your intended outcome and any timing that matters. You do not need a complete brief to begin.
Discuss regulatory supportScope, responsibilities and fees are agreed before work begins.