Writing

Field notes on CMC & getting medicines to patients.

Thought leadership on pharmaceutical Chemistry, Manufacturing & Controls, Quality by Design, and the program leadership that moves complex therapies from discovery to dossier. Long-form guides, plus reference tools you can actually use at your desk.

Field guides

Program Leadership

The Schedule Is the Work

Drug development runs on dates that cannot move, which makes a CMC plan a network problem rather than a to-do list. Five places the usual project tools fail a program, and what a scheduler has to do to close the gap. September 2026 Field guide ~17 min read → Data and AI

AI Under GMP

The rules for machine learning in regulated manufacturing are being written right now, in public. What the draft Annex 22, the rewritten Annex 11 and the FDA credibility framework actually say, and what to build before any of them is final. September 2026 Field guide ~13 min read → Program Leadership

Running the CMC Program

Phase-gated CMC development is not waterfall, and not a startup you can move fast and break things in. Applying agile and lean discipline to regulated development, and knowing exactly where it has to stop. July 2026 Essay ~12 min read → Analytical Development

The Analytical Procedure Lifecycle

Treating an analytical method as a product with a lifecycle, from Analytical Target Profile to Method Operable Design Region, under ICH Q2(R2), Q14, and USP <1220>. July 2026 Field guide ~15 min read → Program Leadership

The Pharma Agile Playbook

Why agile and lean are essential, not optional, in regulated drug development, with worked Scrum and Kanban transformations from lab bench to clinic. June 2026 From the book ~16 min read → CMC Strategy

From Discovery to Dossier: An Integrated CMC Development Roadmap

Phase-appropriate, cross-functional CMC: the four pillars, phase-gated milestones, CDMO technology transfer, and the digital systems that hold it together, mapped to CTD Module 3. April 2026 Field guide ~18 min read → Quality by Design

Quality by Design in Biopharmaceutical Development

A modality-aware guide to building quality into the product rather than testing it in: QTPP, CQAs, risk assessment, DoE, PAT, design space, and lifecycle management under ICH Q8–Q14. February 2026 Field guide ~22 min read →

Reference desk

Three quick instruments distilled from the guides above. They run locally in your browser and nothing you type into them is sent anywhere.

Pharma acronyms, decrypted.

Reference

Every ICH guideline, the parts of 21 CFR that come up, the EU GMP annexes, USP chapters, PDA technical reports and nearly seven hundred acronyms, one thousand and six entries in one searchable box. This replaces the ICH quick reference and the glossary that used to sit here.

Open the pharma acronym finder →

CMC phase-gate navigator.

Roadmap

What CMC owes each development phase, key activities, the decision gate, and the regulatory deliverable.

Reference material is distilled from the guides on this page and harmonized ICH/FDA/EMA sources for quick orientation, always confirm against the current official guideline text before acting on it.