PT&P
Solutions
“Tough enough for the plant. Sharp enough for the boardroom.”
Principal-level validation, CQV, CSV, FDA remediation, and fractional engineering leadership for pharmaceutical, biologics, and medical device organizations. The principal is always in the room.
What PT&P Solutions Delivers
Four service lines. All delivered at the principal level. No junior substitution, no handoffs, no knowledge-transfer loss. The same expert who scopes the engagement executes it, reviews it, and signs off.
What Large Firms Structurally Cannot Replicate
PT&P Solutions competes on three axes that the big consulting houses are architecturally incapable of matching.
“PT&P Solutions is not another consulting firm. It is a precision instrument — wired for complexity, built to deliver, and designed to leave every engagement cleaner, more compliant, and better positioned than it found it.”
Not Looked Up.
Lived.
Twenty-five years in life sciences manufacturing means the regulatory framework is not a reference document — it is the operating environment. Here is what PT&P Solutions works in daily.
| Framework | Area |
|---|---|
| 21 CFR Part 11 | Electronic records & signatures |
| 21 CFR Parts 210/211 | Drug manufacturing (cGMP) |
| 21 CFR Part 820 | Medical device QSR |
| Annex 11 | Computerised systems (EU GMP) |
| ISO 13485 | Medical device QMS |
| GAMP 5 | CSV risk-based approach |
| ICH Q9 / Q10 | Quality risk management / PQS |
| ASTM E2500 | Specification, design & verification |
| cGMP | Current Good Manufacturing Practice |
Where the Work
Has Been Done
Twenty-five years of principal-level engagement across pharma, biologics, and medical device — at organizations where the margin for error is measured in human lives.
Let’s Talk About
What You’re Building.
Whether you need a single validation package, a 483 remediation strategy, or an embedded principal-level engineering lead for a complex capital program — the conversation starts here.