CMC Development Regulatory Strategies Quality Management Systems Qualified Person (QP) GMP Manufacturing CMC Regulatory Affairs Auditing QP Certification CMC Development Strategies Briefing Documents Contract Head of Quality CDMO Search & Management IND, IMPD, CTA Development QP Release Large and Small Molecules ATMPs BLA, NDA, MAA Submissions GMP Certification Quality by Design (QbD) Conceptual Engineering EU Importation

About Cilatus BioPharma Consulting

Cilatus specializes in the management and leadership of CMC Development, GMP Manufacturing, CDMO/CMO Search and Management, Conceptual Engineering, Regulatory Affairs, Quality Assurance, and Qualified Person (QP) Release Services. We have worked on all pharmaceutical product classes, small and large molecule products and ATMP – Drug Substances/APIs, Drug Products, Packaging and Labeling.

Cilatus BioPharma Consulting AG was founded in 2014 and is headquartered in Sarnen, Canton Obwalden, Central Switzerland. In 2017, we established our Qualified person (QP) Certification and Service business, Cilatus Manufacturing Services Ltd., in Dublin Ireland.

We support small, medium and large biopharma companies in strategy development, strategy execution, and operations with our fully integrated consulting team of experienced CMC Development/Manufacturing, Regulatory Affairs, and Quality Assurance professionals. Our consultants are based in Switzerland, Germany, Ireland, and USA and we currently serve clients in South America, USA, Europe and Asia.

CMC Development and Manufacturing Consulting

Regulatory Affairs Consulting

Quality Assurance Consulting

QP Certification Services

CMC Development and Manufacturing Consulting

Regulatory Affairs Consulting

Quality Assurance Consulting

QP Certification Services

Our Values

«We are flexible, responsive, strategic, transparent, efficient, experienced, quality-minded, and patient-oriented»

Our Mission

«We create Value for our Clients through our integrated Team of CMC/Manufacturing, Regulatory Affairs, and Quality Consulting Professionals»

Serving Clients for more than

Years
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More than

Consultants in US and Europe
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More than

Years of combined BioPharma Experience
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More than

Clients served in 4 Continents
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