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How Our GMP Retainer Model Works


How Our GMP Retainer Model Works


Why Use a Retainer?


Retainers are designed for companies that need senior GMP expertise on standby, without the delay, overhead, or inconsistency of project-based consulting.

You receive ongoing support with a fixed number of hours or days per month, ensuring speed, continuity, and compliance when it matters most.



 

What You Get:

Your retainer gives you priority access to senior GMP support—globally deployable, Dubai-based, and regulator-facing.

Typical support includes:


Inspection prep (mock audits, pre-approval inspection readiness)

Quality remediation planning & execution

Ongoing QMS health monitoring

QP/RP coverage (onsite or remote, as permitted)

Internal team coaching and CAPA system optimization

Regulator correspondence drafting & review

Participation in strategy discussions, board calls, or investor meetings

Deployment of specialist consultants as needed (via taskforce model)



 

Retainer Tiers

We offer flexible structures tailored to your operational risk, urgency, and internal capacity.


Tier 1:

Standby Support

  • Email/phone advisory
  • 1–2 live consults/month
  • 72h response window
  • Ideal for: stable sites, QMS upkeep, light-touch compliance



Tier 2:

Active Engagement

  • Weekly calls + document/plan review
  • Regulator response oversight
  • Site inspection simulation & feedback
  • 48h response window
  • Ideal for: sites prepping for inspection or licensing


Tier 3:

Embedded GMP Lead

  • Named point-of-contact + team integration
  • Travel-ready within 24–48h
  • Can operate as interim QP/RP (where permitted)
  • Daily/weekly deliverables
  • Ideal for: crisis remediation, investor scrutiny, post-acquisition risk

All retainers can be upgraded to include on-site deployment, technical project teams,
or transition to turnkey facility delivery.


 

Retainer Tiers

We offer flexible structures tailored to your operational risk, urgency, and internal capacity.


Tier 1:

Standby Support

  • Email/phone advisory
  • 1–2 live consults/month
  • 72h response window
  • Ideal for: stable sites, QMS upkeep, light-touch compliance

Tier 2:

Active Engagement

  • Weekly calls + document/plan review
  • Regulator response oversight
  • Site inspection simulation & feedback
  • 48h response window
  • Ideal for: sites prepping for inspection or licensing

Tier 3:

Embedded GMP Lead

  • Named point-of-contact + team integration
  • Travel-ready within 24–48h
  • Can operate as interim QP/RP (where permitted)
  • Daily/weekly deliverables
  • Ideal for: crisis remediation, investor scrutiny, post-acquisition risk

All retainers can be upgraded to include on-site deployment, technical project teams,
or transition to turnkey facility delivery.


 

How We Work:


Personally led by PJ Murphy (QP/RP-eligible, 20+ years FDA/EMA/MOHAP experience)

Trusted by firms managing FDA/EMA regulatory remediations.

One agreement. One point of accountability. Zero delay.


 

Why Clients Choose Retainers Over Project Work:


Faster access to decision-making expertise

No lag between issue and response

Avoids the friction of re-scoping every small request

Preserves context — no “catch-up” time needed

Trusted presence for regulators, boards, and investors


Let’s Structure a Retainer That Fits

We'll tailor your retainer based on current risk level, inspection calendar, and internal team maturity.

Interested in more solutions?

Interested in more solutions?