Medicines access
IAE provides independent early and expanded access programme consulting for sponsors and delivery teams. Connect route assessment, named-patient or compassionate-use arrangements, programme design and governance with the work needed to put the agreed strategy into practice. Clinical suitability and individual access decisions remain with the responsible teams.
Discuss your access and evidence model
The decision
IAE helps sponsors and marketing authorisation holders plan and oversee medicines access around suitable existing suppliers and systems. We connect country-level regulatory and import requirements, supplier responsibilities, controlled documentation and evidence planning, helping your team retain programme control.
Treating the request as a supply question can leave the wider programme unresolved. Treating it only as a regulatory question can miss the work that sites, partners and patients will depend on.
Start with what already works. Assess the gaps before commissioning another provider or platform, with delegated work, decision authority and acceptance criteria visible to your team.
A connected assessment, a clear recommendation and support for the work that follows.
Assess the proposed activity, relevant jurisdictions and route options. Bring early and expanded access, named-patient or compassionate-use arrangements and company policy into a decision that reflects the actual programme.
Connect request handling, eligibility responsibilities, site readiness, supply, safety reporting and communications. Assess existing suppliers and sponsor-owned systems first; introduce a portal or specialist service only for a defined need.
Work through post-trial access, country additions, provider changes and programme closure. Set the decisions, dependencies and readiness conditions before communicating the transition.
The exact deliverables are agreed for the assignment. Typical outputs include:
Options, recommendations, assumptions and the questions requiring local or specialist resolution.
Sponsor decisions, delegated activities, supplier contracts, reporting access and escalation, with an agreed implementation sequence.
Continuity arrangements, handovers, readiness criteria and decisions for the responsible parties.
An established clinical supply or Good Distribution Practice (GDP) provider may be able to support the proposed access programme. IAE assesses suitability for the specific product, country, site and activity before recommending continuity or a change. Trial-supply authorisation does not establish authority for a different non-trial access route.
The review covers licence scope, import or notification arrangements, release and labelling, transport, returns, safety interfaces and quality agreements. Add a supplier where a demonstrated gap requires it; avoid repeating qualification and onboarding without a reason.
The intended benefit is less duplicated administration and a clearer operating model. Any cost advantage needs to be demonstrated against the same programme scope and your existing cost baseline.
Build evidence planning into the access model from the outset. The evidence and research service considers the question, data, technology and specialist support while keeping treatment and research responsibilities distinct.
Clinical suitability and individual access decisions remain with the treating team and responsible company or programme. IAE provides advisory and implementation support to organisations; it does not arrange treatment access for individuals. Find general information and official routes Formal sponsor or marketing authorisation holder, importer, licence-holder, responsible-person and safety duties remain with the appropriate parties. IAE is not the licensed importer or GDP distributor.
Share the situation, your intended outcome and any timing that matters. You do not need a complete brief to begin.
Discuss your access and evidence modelScope, responsibilities and fees are agreed before work begins.