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About Cilatus Regulatory Services

Cilatus Regulatory Services is a highly experienced Regulatory Consultancy based in Dublin, Ireland. We have extensive EMA, EU, FDA & global regulatory expertise with broad expertise in CMC for biologics, small molecules and veterinary products.

  • Product types
    • Biopharmaceuticals including monoclonal antibodies, recombinant proteins, vaccines, animal, plant and bacteria derived proteins, peptides
    • Small molecules
  • All dosage forms including solid, liquid, parenteral, topical
  • Product classes
    • New biological/chemical entities
    • Biosimilars/generics
    • Orphan drugs
    • Advanced Therapy Medicinal Products (ATMPs)
    • Veterinary products


We provide strategic and operational regulatory support through development, commercialization and life cycle management.