Quality & regulatory compliance for pharmaceutical and medical device manufacturers
Why we exist
Most quality failures are not failures of intent. The procedure exists, the policy is approved, the training record is signed — and the practice on the floor still does not match what the document says. That distance is what an investigator finds, and it is what a warning letter gets written about.
Mrovin closes that distance. We work as practitioners rather than advisors: we hold the pen on the protocol, run the investigation, and sit in the room during the inspection. Every engagement ends in an executed, approved record that survives review.
What we do
Every engagement is scoped to a defined deliverable, a named accountable owner, and a record that survives inspection. We do not hand over advice — we hand over executed, approved, defensible documentation.
Gap assessments, remediation strategy and hands-on execution, led by practitioners who have held the pen on the documents an investigator asks to see.
Protocols authored, executed, deviated and reported to a defensible, ALCOA+ compliant standard — written to be run by your people.
We prepare the people who will be in the room, not just the binders on the shelf.
Expertise
Seven areas account for nearly every observation we are called in to answer. This is what we do inside each one.
The system of record every other control depends on — document control, training, records, internal audit and management review. We build a QMS from nothing, remediate one that has drifted from practice, and integrate separate systems after an acquisition without losing traceability on either side.
Determining the pathway before money goes into the wrong one. We establish classification and route to market, assemble the submission or technical file, and manage the questions that come back — 510(k), De Novo, EU MDR technical documentation and international registrations.
A design history file an investigator can follow from user need to released product. Design inputs and outputs, verification and validation protocols, design reviews, transfer to manufacturing, and a traceability matrix that actually closes.
Your supplier's nonconformance becomes your recall. We qualify and audit suppliers, write purchasing controls and quality agreements that bind change notification, and set incoming inspection to match the risk a component actually carries.
Proving the process does what you say it does, every time. Facility, utility and equipment qualification through IQ / OQ / PQ, process validation and PPQ, cleaning validation, test method validation, and the in-process controls that hold the validated state between runs.
The feedback loop regulators examine first. Nonconformance and CAPA investigations that reach real root cause, complaint handling, MDR and vigilance reporting inside the clock, and change control that keeps the validated state intact.
Risk as a live file, not a document written once to satisfy an auditor. Hazard analysis and FMEA to ISO 14971, benefit-risk determination, and post-market surveillance fed back into the file so the risk profile reflects the product as it behaves in the field.
Standards
21 CFR Part 11 / 210 / 211 · 21 CFR Part 820 / 803 / 806 · ISO 13485 · ISO 14971 · EU MDR 2017/745 · EU GMP Annex 1 & Annex 11 · GAMP 5 · ALCOA+ data integrity
Get in touch
The product, the target market, and where you are in the process. We come back with the pathway and the gaps that stand in it.
hello@mrovin.com
