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You don't need another audit. You need momentum.

Man
Your Momentum Specialists

Affirm8 helps life sciences teams streamline quality assurance, close compliance gaps, and drive continuous improvement through a tailored four-step approach.

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The A-Grade Method

  1. Activate
  2. Assess
  3. Affirm
  4. Accelerate
  5. Advance

Quantifiable Results

  1. Reduce overdue deviations from 55% to 5% in three months.
  2. Increase operational quality* from 65% to 99.8% in 12 months.
The A-Grade Quality Culture Method

The A‑Grade Method. A five-step cultural transformation process that builds momentum, sharpens quality, and sustains results.

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Activate

Your momentum starts here with a quick Direction Diagnostic, revealing if the

A-Grade Method suits your organisation.

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Assess

We dig deep with a diagnostic, revealing broken systems, hidden opportunities, and where cultural momentum has stalled.

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Affirm

From insights to action, we create a roadmap prioritising impact, transforming quality from firefighting into lasting habits.

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Accelerate

We execute your improvement plan with precision, building cultural momentum and delivering measurable performance, compliance, and cultural shifts.

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Advance

We provide ongoing training, support, and updates, ensuring sustainable quality culture and lasting audit confidence.

Testimonials

Trusted by Businesses, Proven by Results

Steve Bond
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I had the privilege of working with Affirm8, I cannot recommend them highly enough. Craig is an exceptional quality assurance professional whose expertise spans Pharmaceuticals, In Vitro Diagnostics, Medical Devices, and Cosmetics. His ability to simplify complex quality processes and drive tangible results is unmatched.

Steve Production manager, BBI Solutions
Mike Hagarty
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During 2San’s scale-up phase, we set ourselves the challenge of achieving ISO 9001 certification within 90 days without disrupting day-to-day operations. Thanks to Craig at Affirm8, we had a fully documented quality management system and a clear implementation plan in place on time. His expertise made certification both achievable and straightforward.

Mike Strategy & Operation Director, 2San
Chris Gregory
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Affirm8 have a mindset of continuous improvement and will always look for and discuss process inefficiencies to create projects to streamline processes. I would highly recommend to anybody taking the opportunity to work with Craig and hopefully our paths will cross again one day.

Chris Production manager, BBI Solutions

From audit chaos to audit confidence in 90 days

If you're still scrambling before every inspection, your system isn't in control - your people are in survival mode.

We embed the habits, rhythms and ownership your team needs to stay ready every day, not just audit day.

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Contact Us

We're here to help you simplify compliance, strengthen systems, and build momentum. Reach out to start the conversation.

Some of our happy clients