Consulting
Independent scientific expertise in pharmacokinetics, preclinical drug development, regulatory writing, and pharmaceutical sciences — available for industry, academia, and research organizations.
Approach
With over 12 years of hands-on experience spanning preclinical research, quantitative pharmacology, regulatory submissions, and academic leadership, I offer focused consulting engagements that bring rigorous scientific thinking to your most complex drug development challenges.
Services
Non-compartmental (NCA) and compartmental PK/TK analyses for preclinical studies. Population PK/PD modeling using Phoenix NLME and Monolix. PBPK simulation and human dose prediction with GastroPlus®. Interpretation and reporting of PK parameters for regulatory submissions.
Typical Deliverables
Strategic design of in vivo pharmacokinetic, toxicokinetic, and efficacy studies. Guidance on species selection, sampling strategy, dose escalation, and study protocol development. Review and critique of CRO-generated study designs and reports.
Typical Deliverables
Authoring and review of GLP and non-GLP study reports supporting IND, NDA, and BLA submissions. CDISC SEND dataset compliance guidance. Preparation of pharmacology and PK sections for regulatory dossiers. FDA 21 CFR Part 11 data management advisory.
Typical Deliverables
Expert guidance on nanoparticle and conventional dosage form development. Design of Experiments (DoE) strategy for formulation optimization. In vitro dissolution method development for nano drug delivery systems. Physicochemical characterization planning and interpretation.
Typical Deliverables
Guidance on LC-MS/MS and UPLC bioanalytical method development and validation for small molecules and nanoparticle formulations. Review of method validation reports for GLP compliance. Platform selection and data acquisition advisory for Waters Empower and Sciex OS.
Typical Deliverables
Development of graduate-level curricula in Pharmaceutics, Biopharmaceutics, Pharmacokinetics, and Drug Regulatory Affairs. SOP and laboratory manual authoring. Research mentorship program design. Peer review and manuscript preparation support for academic researchers.
Typical Deliverables
How It Works
A focused conversation to understand your project scope, timeline, and scientific objectives.
A clear written proposal outlining deliverables, timeline, and engagement terms.
Hands-on scientific work with regular progress updates and open communication throughout.
Final deliverables with a review period to ensure they fully meet your scientific and regulatory needs.
Whether you are seeking a research collaborator, a pharmacokinetics consultant, or an independent scientific expert — I welcome substantive conversations about meaningful work.
Get in Touch