Stoic ScienceGxP Documentation
SOPs, work instructions, deviation reports, change controls, and Certificate of Analysis templates: written to pass review the first time.
What I Offer
GxP documentation and radiopharmaceutical expertise, delivered with precision, on time, audit-ready.
Services
Method Validation & Transfer
Validation protocols and reports for HPLC-RAD, radio-TLC, GC-FID, headspace GC-FID, and wet chemistry methods, including raw material and API testing. Feasibility studies, method transfers, and bridging packages, with validation to ICH Q2(R2).
Radiopharmaceutical Compliance
Radiochemical purity testing SOPs, radiation safety documentation, lab setup, and waste management procedures for radiopharmaceutical operations.
One of very few consultants with hands-on GxP radiochemistry lab management experience.
Instrument Qualification
IQ/OQ/PQ protocols and reports for HPLC and GC systems, dose calibrators, and radio-TLC scanners, for smaller labs that do not yet have their own qualification program.
GxP Training
Practical training for lab and QC teams: radiation safety, radioactive sample handling, radiation safety documentation, good documentation practice, and working to SOPs. I have trained lab staff throughout my career.
Standards I work to
- 21 CFR 211
- 21 CFR 212
- USP <823>
- ICH Q2(R2)
- EU GMP Annex 15
Typical situations
Where I can help.
- A new radiochemistry lab needs its SOPs written before go-live.
- A radio-HPLC method has to move to a new site or a new instrument.
- A small lab has new instruments and no qualification program.
- A team needs practical radiation safety training: handling radioactive samples, and the documentation that goes with it.
How Engagements Work
Three flexible models designed to fit where you are.
Project-Based
Fixed scope, fixed fee. A single SOP, a validation package, or a full documentation package. Ideal for defined one-time needs.
Retainer
Ongoing monthly support for documentation management, deviation tracking, and continuous compliance needs. Predictable cost, consistent availability.
Advisory
Hourly SME consultation for specific regulatory questions, documentation review, or technical decision support. Pay only for what you need.