Cilatus Biopharma

Pre-clinical

Dublin, IrelandFounded 2014cilatus.com

Cilatus BioPharma Consulting AG is a global provider of integrated technical and regulatory consulting services for the biopharmaceutical industry. The company leverages a team of over 10 consultants across the US and Europe, with more than 100 years of combined experience, to guide clients through CMC development, GMP manufacturing, CDMO selection, regulatory strategy, and Qualified Person (QP) release services. Its mission is to create value for clients through a flexible, experienced, and patient-oriented team, having served over 100 clients across four continents since its inception.

Founded

2014

Employees

10-20

Focus

OncologyImmunology

AI Company Overview

Technology Platform

Cilatus does not own a drug technology platform. Its core offering is an integrated consulting service model combining deep expertise in Chemistry, Manufacturing, and Controls (CMC), Regulatory Affairs, and Quality Assurance to guide client drug development programs.

Opportunities

Growth is driven by the increasing outsourcing of CMC and regulatory functions by biopharma companies, especially in complex modalities like ATMPs.

The company's EU QP services from Ireland provide a strategic advantage for clients targeting the European market, and its integrated consulting model is a key differentiator in a fragmented market.

Risk Factors

Key risks include high dependency on key personnel and their reputations, susceptibility to cuts in client R&D budgets during economic downturns, and intense competition from both large global consultancies and solo practitioners.

The service-based model has limited scalability without proportional increases in headcount.

Competitive Landscape

Cilatus competes with large strategy consultancies (e.g., McKinsey), specialized life science consultancies (e.g., Parexel, NDA Group), and boutique firms. Its differentiation lies in its integrated CMC/Regulatory/Quality team, hands-on operational experience from senior consultants, and direct access to EU Qualified Person services through its Irish entity.