Services
Scientific & Regulatory Support for Environmental Fate, Metabolism & Residue Chemistry
Regulatory Strategy & Roadmaps
US, EU, Japan, Canada, Brazil, and global pathways with a focus on data‑gap closure and dossier planning.
Clear, defensible strategies aligned with regulatory agencies' expectations
GLP Study Plans & Oversight
Protocol design, CRO selection, interim review, and development of defensible narratives.
Support spans early planning through final reporting to ensure GLP integrity and regulatory acceptance.
Complex Chemistry Troubleshooting
Bespoke designs for atypical degradation or metabolism challenges.
Scientifically credible justifications that withstand agency scrutiny.
Dossier Readiness & Agency Responses
Readiness sprints, responses to deficiency letters, and preparation for regulatory meetings.
Your submissions tell a coherent scientific story and anticipate reviewer questions.
Mentoring & Capability Building
Study Director curriculum, QA‑aligned checklists, and leadership development for technical teams.
Ideal for organizations building internal regulatory or scientific capability.