Quality Assurance

Regulatory Inspection Readiness

An inspection should be a normal business day

We support GxP-regulated companies before, during and after inspections by the FDA and EU/EEA competent authorities: from mock inspections and readiness assessments to back-room support, inspection responses and remediation programs. The goal: a state of permanent inspection readiness, without ad-hoc actions.

20+ yearsTrack record as inspection readiness partner
Top 20 Pharma & MedTechPreferred supplier
FDA & EU/EEAInspection experience, with local on-site support

The essentials

What is inspection readiness?

Inspection readiness means your facility, quality systems, records, people and operations can demonstrate a state of control at any moment, not only when an inspection is announced.

It covers the full inspection lifecycle: preparing sites and teams before the inspectors arrive, supporting them while the inspection takes place, and responding to and remediating any findings afterwards.

Done well, it becomes a permanent state rather than a recurring, costly preparation effort.

Quality assurance specialist reviewing inspection documentation in a pharmaceutical laboratory.

Our approach

How we support you

Our inspection readiness support is organized around three types of efforts, depending on where you stand.

Immediate readiness efforts

When

You have received an inspection announcement.

How we respond

A rapid assessment to close out open events, review open non-conformances and CAPA records before they are presented to inspectors, war room support, a mock inspection and SME preparation.

Remediation efforts

When

You have received a Form 483, a Warning Letter or a major/critical audit finding.

How we respond

A response and commitment strategy, a remediation plan, CAPA governance and development of the evidence that demonstrates your commitments have been met.

Preventive efforts

When

Your quality system works well and you want to stay inspection-ready between inspections, or you face a CAPA backlog, adverse trends, an upcoming launch, weak audit results or high recurring inspection preparation costs.

How we respond

A baseline assessment, a roadmap, a mock inspection and a sustainable readiness program, with ongoing support such as periodic risk reviews, refresher mock inspections and staff preparation.

“Inspection readiness isn’t just about passing an inspection. It’s about building confidence in your quality systems, every day.”

Common scenarios

When we help

Maintaining readiness between inspections

Your quality system is in good shape and you want to keep it that way. We provide ongoing support between inspections: periodic risk reviews, refresher mock inspections, SME coaching and interview practice, and readiness checks after organizational or regulatory changes.

Result

Inspection readiness becomes part of daily operations, not a last-minute effort.

Result

Inspection readiness becomes part of daily operations, not a last-minute effort.

Areas of expertise

Our capabilities

From a single gap assessment to a multi-site remediation program:

Mock inspections
Gap & readiness assessments
Front room & back room support
SME coaching & interview practice
Inspection team preparation
Inspection response & remediation
CAPA backlog recovery
Data integrity
Computerized system readiness
Validation & state of control
Sterile manufacturing & contamination control
Laboratory readiness
Supplier & CMO readiness
Readiness governance

Proven results

Reference cases

Pharmaceutical quality assurance professionals reviewing documentation during a mock inspection preparation.

Sterile pharma manufacturer

Mock FDA inspection and remediation

Challenge

A sterile manufacturing and API site in Curaçao needed to prepare for an FDA inspection, with compliance, qualification and validation gaps to close.

Approach

Mock FDA inspection, quality system review and manufacturing assessment, followed by a remediation plan with CAPA coordination and execution: laboratory/QC improvements, validation execution and data integrity remediation. Front-room/back-room preparation, facility walkthroughs and batch/data trace exercises, with a team of up to 25 experts deployed on-site.

Result

The subsequent FDA inspection was completed successfully with no critical or major observations.

Quality control specialist examining a pharmaceutical vial alongside an automated production line.

Swiss CMO

FDA readiness for a new product

Challenge

A pharmaceutical CMO with sterile manufacturing sites faced an FDA inspection linked to a new product, under both FDA and EU regulations.

Approach

An FDA inspection readiness program: mock FDA inspection, assessment of quality system, manufacturing, laboratory/QC and validation, data integrity review, pre-inspection documentation review, SME interview preparation, front-room/back-room preparation and batch/data trace exercises.

Result

The FDA inspection was completed successfully with no critical or major observations. Qualification and validation gaps were resolved before the inspectors arrived.

Pharmaceutical quality assurance professionals collaborating on inspection preparation and regulatory documentation.

Medical device CMO

FDA inspection preparation and support

Challenge

A multi-site medical device CMO in the Netherlands, producing 3D-printed titanium prostheses, prepared for FDA and ANVISA inspections under FDA and ISO 13485 requirements.

Approach

Pre-inspection documentation review, on-site assessment, walkthroughs and batch/data trace exercises, a QMS update, and QMS and inspection training including front-room/back-room preparation, followed by support during the inspection and with the responses.

Result

Inspection completed successfully with no critical or major observations.

Your partner

Why QbD Group for inspection readiness?

With a 20+ year track record as an inspection readiness partner, QbD Group is a preferred supplier for Top 20 Pharma and MedTech companies.

Former FDA investigators

Access to our network of former FDA investigators, who know how inspections are conducted from the inside.

FDA and EU GMP expertise, local presence

Deep expertise in FDA (21 CFR 210/211/820) and EU GMP requirements, including Annex 1 and Annex 11, with local on-site support in the US and Europe and remote delivery where it makes sense.

Emergency Response Team

Inspection announced or Warning Letter received? Our Emergency Response Team mobilizes experienced experts quickly.

The latest FDA approach

The FDA increasingly uses AI and data analytics to target and prepare inspections. We prepare you for how inspections are conducted today.

End-to-end capabilities

Mock inspections, readiness assessments and remediation, from a single site visit to a multi-workstream program.

Permanent readiness with VLMcare

VLMcare continuously monitors your validation status and flags drift, so you stay inspection-ready between inspections.

Partner with us

Let's talk Quality Assurance

Whether you need QMS setup, audits, or ongoing compliance support, our QA experts are ready to help.