Our EXPERTISE

Our broad development and regulatory experience and our commitment to lean development, scientific excellence, regulatory strategy, and apt deployment of new methodologies guarantee that we will together chart the best possible development path for your new molecular entity.

  • Modalities

    Small molecules

    Monoclonal antibodies

    Enzymes and fusion proteins

    Antibody drug conjugates

    Bi- and tri- specific

    Oligo-based therapeutics

    Delivery technologies

  • Studies

    Design, outsource, oversee, and interpret in vitro and in vivo nonclinical studies

    Pharmacology

    Pharmacokinetics

    Safety pharmacology

    Discovery and investigative toxicology

    GLP regulatory toxicology

  • Regulatory

    Nonclinical development strategy from IND to registration

    Prepare briefing documents and represent Sponsor in regulatory interactions

    Author Investigator’s Brochures

    Prepare DART and CARC waivers

    Author nonclinical sections (m2, m4) of regulatory filings

  • Other Services

    Excipient assessments

    Impurity assessments

    Extractables and leachables

    Permissible daily intakes

    Occupational health (OHC/OEL)

    Due diligence support

    Manuscript authoring

Let’s work together

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We can’t wait to hear from you!