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EXPERTISE

Small and flexible team of experts who have helped >100 clients solve drug development challenges through outside-the-box solutions and strategies

Regulatory Expertise

  • Experience with FDA, EMA, PMDA,

  • Deep knowledge of current perspective and study designs to satisfy regulators

  • Work with client regulatory authorities and clinical investigators questions/concerns

  • Assist in nonclinical toxicity concerns for clients on clinical holds

Experience Across a Range of Therapies

  • ​​​Monoclonal antibodies

  • Bispecifics and trispecifics

  • Therapeutic proteins

  • Enzyme replacement therapies

  • Peptides

  • ASOs/DNA/RNA based therapies

  • Antibody Drug Conjugates (ADCs)

  • Fusion proteins

  • Cytokines

  • Cell and gene therapies

  • Small molecules​

Broad Range of Disease Indications

  • Oncology

  • Autoimmunity

  • Ophthalmology

  • Rare diseases

  • Anti-virals

  • Anti-infectives

  • Neurology

  • Pain

  • Psychiatry

LEARN MORE ABOUT US

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