Quality & Regulatory Compliance

We build the record that holds up.

Mrovin is a quality and regulatory compliance consultancy for pharmaceutical and medical device manufacturers. We close the distance between what the regulations require on paper and what actually happens on a manufacturing floor.

Get in touch What we do
15+ years
in regulated manufacturing
10+ frameworks
in active regulatory practice
500+ documents
QMS integrated across acquisitions
50 systems
qualified through IQ / OQ / PQ

What we do

Three ways we work with manufacturers

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.

01

Consulting

Gap assessments, remediation strategy and hands-on execution, led by practitioners who have held the pen on the documents an investigator asks to see.

  • Regulatory gap assessment
  • Remediation strategy & sequencing
  • QMS build-out and integration
  • Interim quality leadership
02

Validation & Qualification

Protocols authored, executed, deviated and reported to a defensible, ALCOA+ compliant standard — written to be run by your people.

  • Facility, utility & equipment qualification
  • Process validation and PPQ
  • Cleaning and test method validation
  • CSV and Part 11 data integrity
03

Training & Inspection Readiness

We prepare the people who will be in the room, not just the binders on the shelf.

  • Role-based GxP and SOP training
  • Mock FDA / notified body inspections
  • 483 and observation response
  • CAPA investigation coaching

Expertise

The control areas regulators actually examine

Quality Management Systems Regulatory Affairs Product Realization & Design Controls Supplier Controls Manufacturing, Production & Process Controls Quality System Controls Risk Management

Standards we work to

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

Partners

Who we work alongside

AmCham Oman
American Chamber of Commerce in Oman Ministry of Health
Sultanate of Oman Medical Engineering Consultants
Quality & regulatory engineering

Get in touch

Let's build the record that holds up

Telephone
+1 630 881 7998
Email
hello@mrovin.com
Office
New Hampshire, United States
Web
www.mrovin.com
Start here

Tell us what you're preparing for

Send us the product, the target market and where you are in the process. We'll come back with the pathway, the likely gaps and what it takes to close them.

hello@mrovin.com Email us

We reply to every enquiry within one business day.