NST provided quality review for a broad range of regulatory documents, including:
We were also contracted to provide medical writing and editorial support as well as general QX function for all regulatory submission documents.
"“I cannot praise the Niche team highly enough, having been a huge support from the outset – we quickly built up a great relationship, they are very supportive, responsive to all my emails and incredibly approachable and friendly. They have made it clear that they are always there when we need them."
NST began work with Adaptimmune in 2024, conducting a QC review of an IB update for uzatresgene autoleucel, one of Adaptimmune’s TCR-based therapies. NST went onto play a pivotal role with the team responsible for the delivery of Adaptimmune’s regulatory documents. Adaptimmune appreciated NST’s flexibility and range of skills, meaning assistance could be scaled to address any of their medical writing needs across a broad range of regulatory documents for their various development assets.
NST established clear lines of communication with the Adaptimmune team to enable close tracking of multiple documents across a variety of projects with ambitious timelines. All documents were delivered to the highest quality and according to the agreed timelines.
From Phase 2 through to the global Phase 3 HEAL-MI trial, Niche has been Recardio's trusted writing and regulatory.
read moreNiche built and coordinated the full communications strategy for this 20-institution European initiative, turning.
read moreWhen stalled regulatory documentation threatened to derail their neurological programme, Cleothena turned to Niche —.
read moreAt the height of the pandemic, Niche's rapid manuscript writing helped Synairgen publish their landmark interferon beta.
read moreNiche supported Nabriva's antibiotic lefamulin from early clinical protocols all the way to FDA, EMA and Health Canada.
read moreNiche provided Astex with expert regulatory writing across their oncology pipeline, delivering clinical protocols, study.
read morePutting patients first, Niche supported ViiV Healthcare's global HIV outreach programmes with medical writing,.
read moreOver a decade and 20+ guidelines later, Niche remains the BSH's trusted partner for raising haematology care standards.
read moreFor over a decade, Assign DMB relied on Niche as their embedded writing partner, seamlessly converting statistical.
read moreA trusted writing partner to this Belfast-based early-phase CRO for over a decade, Niche turned BioKinetic Europe's.
read moreNiche served as the English-language regulatory writing backbone for this Nordic consultancy, producing IBs, IMPDs and.
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