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Niche partnered with Erytech Pharma to rescue and rewrite substandard clinical study reports, delivering a high-quality regulatory package...

Niche provided DemeRx with end-to-end support to launch a pioneering ibogaine addiction trial, covering site identification, regulatory...

Niche played a foundational role in securing EMA approval for Strimvelis, the world's first ex vivo autologous gene therapy, and continues...

When an Alzheimer's programme hit a wall after two negative Phase III trials, EVERSANA called on Niche to make sense of the data and chart a...

The clinical evidence Niche helped generate for Funxional's novel anti-inflammatory compound FX125L proved compelling enough to attract...

Niche prepared the full regulatory package for HOOKIPA's groundbreaking arenavirus immunotherapy platform, enabling the world's first...

What began as a CSR writing request grew into a broad regulatory partnership, with Niche guiding iOnctura's roginolisib programme through...

Regulatory documentation, ILAP designation and a robust clinical protocol for the Sunlight Trial — Niche helped Nanomerics take their...

Working from poor quality hard copy source materials, Niche rescued and rebuilt Thromboserin's Investigator's Brochure for TH001, laying the...

From Phase I protocols to a full Marketing Authorisation Application, Niche was VectivBio's embedded regulatory writing partner throughout...