NEW EXPANDED SERVICES!
  • Solid State Characterization / Form Control

  • Salt and Polymorph Selection

  • Disproportionation

  • Method Validation and Transfer

  • Specification Development

  • CRO Strategies and Management

  • Peptide and Protein Therapeutics

Stress Testing / Forced Degradation Studies
  • Overall Strategy
  • Design, Execution, and Interpretation of studies
  • Leveraging for Analytical Method Development
  • Leveraging for Mechanistic Investigations
  • Regulatory Module Authoring / Review
Photostability / Photochemistry
  • Design, Execution, and Interpretation of ICH Q1B Studies
    • Forced degradation
    • Confirmatory
  • Patient In-Use Studies
  • Photochemistry / Mechanistic Investigations
Analytical and Mutagenic Impurity Control Strategies
  • Design / Development of Analytical Methods
    • “Ordinary” Impurities
    • Genotoxic / Mutagenic Impurities
  • Trouble-Shooting Analytical Methods
  • Solving Analytical Artifact Issues
  • Leveraging Forced Degradation Studies
  • Process Impurity Discovery, Structure Elucidation, and Mechanistic Chemistry
  • Analytical Method Development
Chemical, Physical, and Environmental Stability / Degradation
  • Degradation Chemistry

    Degradation ForecastingScreen Shot 2015-03-03 at 10.16.28 AM

    • Degradation Product Identification / Structure Elucidation
    • Degradation Pathway Determination
    • Mechanistic Investigations
      • Kinetics
      • Degradation reaction mechanisms
      • Computational Chemistry
        • Bond dissociation enthalpy calculations for oxidative susceptibility determinations
        • Geometry optimization calculations
        • Reaction pathway barriers
    • Mass balance investigations
    • Literature precedence / literature searching

    Stability

Scientific Staff Development
  • Seminars / Training
  • Technical Writing Skills
  • Developing an Internal / External Sphere of Influence
  • Scientific Manuscripts and Presentations
    • Developing the manuscript / presentation
    • Authoring, assistance with authoring, proofing
Global Regulatory Submissions and Issues
  • Authoring / Review of Regulatory Submissions
  • Responding to Regulatory Agency Questions
Pharmaceutical CM&C Due Diligence Assessments
  • In-licensing and Out-licensing
    • Analysis of Analytical / Formulation aspects of potential licensing candidates
    • Available for global travel, as needed.
Formulation Design and Stabilization
  • Drug-Excipient Compatibility Studies
  • Drug-Excipient Interactions
  • Formulation-Induced Instability
Legal / Expert Witness / Patent Disputes
Linkedin Profile Graphic & Link
ResearchGate Profile Graphic & Link
Google Scholar Profile Graphic & Link