Services NST 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 NST for regulatory documentation preparation, on the recommendation from a business partner. NST was given accountability for clinical trial application documents, pivotal to the early development of the LCMV technology. NST 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.
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