One year ago, today, Biostrategenix was born after I was laid off from my last company. That was the push I needed. Today, with amazing support from my family and friends, Biostrategenix is thriving and we are poised to and on the cusp of achieving so much more in coming years.
When I started Biostrategenix, the idea was simple. Biopharma companies are being asked to do more with quality systems. I knew people who could fix them, and many were former colleagues. So, I set out to match the right experienced person to the right problem, and to do the work myself wherever I could.
The market did not hold still
You cannot expect the market to stay calm, and it did not. The tariff proclamation on imported patented pharmaceuticals reached its second effective date on 29 September, and the reduced 20 percent rate it offers is tied to an onshoring plan whose milestones run to January 2029 and may be audited by an outside firm. That turned technology transfer schedules into financial inputs, and it put a premium on experienced quality and validation staff, who cannot be hired in parallel the way buildings can be built.
At the same time, artificial intelligence moved from conference slides into investigation and records systems, and regulators are writing the rules while people are already using the tools. In Europe, the draft Annex 22 on AI and the revised Annex 11 on computerized systems went out for consultation in 2025, and as of this week the published EudraLex Volume 4 still shows the 2011 versions. Sites are being asked to plan for rules that have not been finalized.
Underneath all of this, many teams are working with fewer people, tighter dates and more scrutiny than they had a year ago.
What the first year looked like
In the first year I worked with companies across the United States on quality systems, investigations and CAPA, and on the staffing needed to run them. I am grateful to every client who trusted a new firm with real problems, and to every former colleague who helped or worked alongside me. A firm built on relationships depends on people being generous with them, and I was fortunate to be on the receiving end of that generosity.
The work also confirmed a pattern I write about often on Decoded. Many of the quality problems that reach a regulator are investigation problems that arrived late. A site closes a deviation on the nearest defensible cause, the corrective action addresses the event instead of the system, and the same failure returns somewhere else. Fixing that is rarely a matter of more effort. It is a matter of changing what an investigation is allowed to conclude and what the quality system measures afterward.
How Biostrategenix works
The model is deliberately simple. I lead the work personally, and when a scope needs more depth I add named senior specialists who have a defined role and a CV the client sees before work begins. Engagements usually start with the Rapid Diagnostic, a fixed-scope review that can be completed in as little as two weeks, depending on the scope, and that finds what is actually happening in a client’s own records and sets out a prioritized sequence for fixing it.
What comes next
There is much more to come next year. I expect to do more work with sites across the US, to go deeper in the areas where I see quality teams most exposed, namely investigations that reach root cause, remediation programs that hold up under regulatory scrutiny, and contamination control, and to keep writing here about what I find.
If you are a former colleague who wants to work on hard quality problems, or a company with one, I would like to hear from you. The Rapid Diagnostic is the quickest way to start.
Key Takeaways
- The company began with a practical idea. Match the right experienced person to the right quality problem, and do the work personally where possible.
- The market has not been calm. Onshoring deadlines, AI governance and draft EU rules all arrived in the same year.
- The core pattern held. Many problems that reach regulators are investigation problems that arrived late.
- Year two builds on the first. More work with US sites, and more depth where quality teams are most exposed.