Agyra Ltd Information

Agyra is a specialist regulatory affairs consultancy working with early-stage biotech and pharma companies, typically from pre-IND through to end of Phase 2, to build regulatory strategy around their goals and objectives, not the other way around. Agyra partners with founders, executive teams, and investors to co-create regulatory approaches that serve their scientific and commercial objectives, with expertise across FDA, EMA, MHRA, and PMDA. Services are built around three core pillars: 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐲: Designing regulatory pathways built around scientific and commercial goals, identifying opportunities to expedite development through designations such as Fast Track, Breakthrough Therapy, PRIME, and ILAP, and building regulatory milestones that generate investor confidence at critical stages of growth. Deep expertise in oncology and haematology. Leadership: Providing experienced interim and fractional senior regulatory leadership to guide critical development decisions, support executive teams, and provide oversight of regulatory vendors and due diligence exercises. Mentoring: Supporting in-house regulatory professionals and cross-functional teams to build the strategic mindset, commercial awareness, and influence needed to navigate an environment where the answers are rarely written down.