Services Niche provided to HOOKIPA Pharma included:
"As a small company with limited resources, we had to outsource our regulatory package. The documentation produced was to a high quality and very tight timeline and resulted in a positive recommendation from the health authority."
In order to realise their pioneering vision for the arenavirus platform, Hookipa Pharma have worked with a number of trusted partners. HOOKIPA began a fruitful collaboration with Niche for regulatory documentation preparation, on the recommendation from a business partner. Niche was given accountability for clinical trial application documents, pivotal to the early development of the LCMV technology. Niche writers assisted in the preparation of regulatory documents, leading to the first first-in-human studies exploring the safety and immunogenicity of a LCMV-based vaccination vector. These included the Investigator’s Brochure and IMPD (including a challenging CMC, clinical and non-clinical components for this groundbreaking technology). These documents, produced efficiently to a high quality, resulted in a positive recommendation from the health authority.
When an Alzheimer's programme hit a wall after two negative Phase III trials, EVERSANA called on Niche to make sense of.
read moreNiche provided DemeRx with end-to-end support to launch a pioneering ibogaine addiction trial, covering site.
read moreNiche played a foundational role in securing EMA approval for Strimvelis, the world's first ex vivo autologous gene.
read moreNiche partnered with Erytech Pharma to rescue and rewrite substandard clinical study reports, delivering a high-quality.
read moreThe clinical evidence Niche helped generate for Funxional's novel anti-inflammatory compound FX125L proved compelling.
read moreWhat began as a CSR writing request grew into a broad regulatory partnership, with Niche guiding iOnctura's roginolisib.
read moreRegulatory documentation, ILAP designation and a robust clinical protocol for the Sunlight Trial — Niche helped.
read moreWorking from poor quality hard copy source materials, Niche rescued and rebuilt Thromboserin's Investigator's Brochure.
read moreFrom Phase I protocols to a full Marketing Authorisation Application, Niche was VectivBio's embedded regulatory writing.
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