What I Offer

Full-lifecycle GxP documentation across every phase of pharmaceutical development. SOPs, analytical methods, and Work Instructions to qualification protocols, deviation management, and release documentation — written to the regulatory standard the context demands.

Validation protocols and reports across the full spectrum of analytical techniques — chromatographic, spectroscopic, electrochemical, and radiochemical. 

Feasibility studies, method transfers, and bridging packages built to ICH Q2(R1) standards.

Specialized GxP documentation for radiopharmaceutical  operations — radiochemical purity testing, radiation safety programs, lab setup, waste management, and instrument qualification. One of very few consultants with hands-on GMP radiochemistry lab methods and management experience.

Fixed scope, fixed fee. A single SOP, a validation package, or a full documentation audit. Ideal for defined one-time needs.

Ongoing monthly support for documentation management, deviation tracking, and continuous compliance needs. 

Predictable cost, consistent availability.

Hourly SME consultation for specific regulatory questions, inspection preparation, or technical decision support. Pay only for what you need.