Early Development Consulting Services
Pharmacology Expert for Module 4
Leverage extensive pharmacology expertise to support the preparation of Module 4 (Nonclinical Study Reports) of the Common Technical Document (CTD). This includes comprehensive pharmacokinetic, pharmacodynamic, and toxicology studies, ensuring that all regulatory requirements are met, and that the data presented is thorough and compelling.
IND-Enabling Study Design
Design and oversee IND-enabling studies, ensuring they meet regulatory requirements and provide the necessary data to support Investigational New Drug (IND) applications.
Assay Expertise
Serve as a subject matter expert in pharmacokinetic (PK), pharmacodynamic (PD), and anti-drug antibody/neutralizing antibody (ADA/NAb) assays, providing critical insights and guidance to ensure accurate and reliable results.
Immunogenicity
Assess and mitigate immunogenicity risks associated with therapeutic candidates, developing strategies to minimize adverse immune responses and enhance drug safety.
Study Reports and Memos
Craft detailed study reports and memos that clearly communicate study objectives, methodologies, results, and conclusions, ensuring comprehensive documentation and effective communication with stakeholders.
Potency Assays
Develop and validate potency assays to accurately measure the biological activity of a selected candidate.
Regulatory Feedback
Provide expert biology and pharmacology feedback to regulatory authorities, addressing any concerns and facilitating the approval process by demonstrating the safety and efficacy of drug candidates.
