Services

Every project starts here, because what an authority outside the US and EU will accept depends on what is already in your dossier. We review your EU or US dossier and the assessment reports against each target market’s requirements, and tell you early which markets can take a reliance route, what is missing, and what will cause questions later.

What you get: a market-by-market gap analysis, the recommended route for each market, and a realistic timeline.

Many authorities will run a shorter review when the submission is built on the FDA or EMA assessment, but only if the dossier is shaped for that from the start. We choose the route (abridged, reliance-based or full), prepare and lead the pre-submission meetings, put together the local dossier, and handle the questions that come back during review.

What you get: the submission package and support through to approval.

In many markets the price is approved as part of registration, so a filing without a pricing strategy is only half done. We prepare the pricing submissions and reference price analysis, and where an authority or payer asks for health economic evidence, we put the economic case together with specialist modelling partners.

What you get: a pricing strategy per market, the pricing submissions, and coordination of any health economic work.

Where you already have a local affiliate or partner, we work with them remotely as they prepare their own submission. We agree the strategy, anticipate the questions their authority is likely to raise and plan answers in advance, and help draft responses during review, so the local team is not facing a first-time ATMP review alone.

What you get: a readiness review, a list of likely questions with suggested positions, and drafting support during review.

An approval means little until a hospital can actually treat. We map the haematologists and transplant physicians who will drive early use in each market, and take their centres from first contact to ready to treat, covering site qualification, chain of identity, apheresis and the logistics of moving cells out and finished product back, working with your supply and medical teams so the first patient goes through without gaps.

What you get: a KOL and centre map, a centre activation plan, qualification packs, and coordination up to the first treatment.

Advanced therapies come with risk management commitments that local authorities often negotiate product by product. We agree the risk management plan with the authority, build the additional risk minimisation materials it requires, such as patient alert cards, caregiver training and CRS and ICANS guidance for treating teams, and set up the long-term follow-up and reporting that goes with them.

What you get: an agreed risk management plan, localised risk minimisation materials, and a working PV and reporting set-up.

Before any money is spent on filing, we look at whether the market is worth entering and how: the disease and patient numbers, current treatment, competing products and their prices, how products are funded, and who the real buyers are, whether hospital tenders, government or private insurers.

What you get: a market-by-market assessment with a clear recommendation on which markets to enter first.

We set out the fastest realistic route in each market, including reliance on FDA or EMA approval where the authority allows it, then prepare the local dossier and manage the review through to approval.

What you get: a regulatory plan per market, the submission package and support through review.

Where the price is set as part of registration, we analyse reference prices and the local pricing rules, and build a pricing position that works for both the authority and your global price strategy.

What you get: a pricing analysis and the pricing submissions.

The local partner often decides whether a launch succeeds, and changing partners later is slow and expensive. We build a shortlist, assess each candidate’s regulatory capability, cold chain and quality systems, pharmacovigilance and commercial reach, and support you through the selection and the quality and PV agreements that sit alongside the commercial contract.

What you get: a partner shortlist with assessments, a recommendation, and support through to signed agreements.

Once the product is launched, we can stay on to oversee the partner’s regulatory, quality and PV performance on your behalf, so problems surface before they reach the authority.

What you get: regular oversight reviews and escalation when something needs your attention.

When a portfolio changes hands, every marketing authorisation in every market has to move to the new holder, together with the CPPs, artwork, pharmacovigilance responsibilities and supply, and the product has to stay on the shelf throughout. We run the regional side of these transitions: we plan the transfer route and sequence for each market, coordinate the regulatory, supply, quality and commercial teams on both sides of the deal, and manage the timelines through closing and into the transition service period.

In many of these markets a change of manufacturing site or licence holder means a new price certificate, and sometimes a new price, so we check the price impact market by market before the transfer is filed rather than after.

What you get: a market-by-market transfer plan, a cross-functional transition plan, and project management through to completion.