TS MGMT
Research
Scope the problem on site and in your records.
You keepWritten current-state assessment
TS MGMT LLC · Bangor, Pennsylvania
Built to pass inspection.
Pharmaceutical consulting and lab start‑up, run to the standard an FDA investigator expects.
Current engagementQC laboratory start‑up
119days to first sample
Regulatory scope
- FDAUnited States, 21 CFR 210/211
- EMAEuropean Union, EU GMP and Annex 1
- MHRAUnited Kingdom
- Health CanadaCanada
- PMDAJapan
- WHO GMPGlobal prequalification
Credentials
- 503A and 503B compounding: facility design and compliance
- Lean Six Sigma, Green Belt
- B.S. Biotechnology and Biochemistry
- Aseptic fill and finish, Grade A through D
- Packaging engineer
- Project manager
- Vendor management
- Internal and external audits
Pharmaceutical work, end to end.
Fix what an inspector found, or build what an inspector will find.
How every engagement runs.
Four steps. Each one ends in a document you keep.
Review
Rank every gap by patient and product risk, following ICH Q9(R1).
You keepRisk register
Speculate
Model the options, costs, and timelines before committing.
You keepDecision record
Execute
Deliver, then prove it worked with effectiveness checks.
You keepAudit-ready closure package
How we work.
Standards earned in sterility assurance, FDA remediation, and laboratory start-up.
- Patient safety first.
- Inspection-ready, every day.
- Root cause, not symptoms.
- Risk-based decisions, documented.
- Every CAPA closed and proven effective.
- Right first time, then better.
- Quality from the floor to the boardroom.
Who do you need?
Pick a desk and you reach the right person directly. Mutual NDA before any document review.
(610) 653-8362TS MGMT LLC · info@tjsmgmt.com
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