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Our Specialised Programs

1

Contamination Control

Still don’t have a complete Contamination Control Strategy?
Our CCS in 6 Weeks program delivers a fully compliant, inspection-ready CCS,  built with you, step-by-step, by industry experts.
Stop guessing. Start leading with confidence.

2

FDA Warning Letter

Received an FDA Warning Letter?
Our 7 Day Rapid Response program delivers a complete, compliant reply, fast and focused.
Work step-by-step with our experts to assess gaps, define corrective actions, and prepare a credible FDA-ready response.
Start recovering with confidence.

3

Cosmetic Compliance

Bringing a cosmetic product to the EU market? Our EU Cosmetic Compliance program delivers a full regulatory pathway, fast and compliant.
Work step-by-step with our experts to prepare your PIF, CPSR, and quality system documentation.
Launch with confidence.

4

GMP Audit Ready

Facing an impending regulatory inspection or internal audit?

Our GMP Audit Ready program identifies cGMP and Annex 1 gaps fast and equips your site with structured remediation plans, tools and documentation. Work with us to assess risks, close gaps and present with confidence. Act now, protect compliance and inspection outcomes.

5

Facility Compliance

Is your facility fully aligned with GMP expectations?
Our Facility Compliance program delivers a clear, structured roadmap to restore and sustain full regulatory compliance.
Work step-by-step with our experts to close gaps, strengthen systems, and prepare for inspections.
Identify risks, get compliant and stay inspection ready.

6

Barrier Technology

Planning a new RABS or isolator installation?
Our Barrier Technology program delivers complete compliance support, from URS and Technical Specification to IOPQ execution.
Work with our experts to design, qualify, and document barrier systems that meet global GMP expectations. Build it right and validate with confidence.

7

Rapid Remediation

Facing urgent cGMP compliance gaps or regulatory findings?

Our Rapid Response Remediation program delivers a fast, structured remediation roadmap with expert guidance. Work step-by-step with our consultants to build an audit-ready Quality Remediation Plan. Act now, work with us, protect compliance, operations products and patients.

8

Drug Shortages

Facing a potential or active HPRA drug shortage?
Our Drug Shortage Remediation program delivers a structured, compliant recovery plan, fast.
Work step-by-step with our experts to identify root causes, stabilise supply, and implement sustainable controls.

Act quickly, work with us,

protect patients and compliance.

9

CC Academy

Struggling to secure experienced contamination control operators or sterility specialists?

Our Contamination Control Academy identifies, trains and deploys GMP-ready specialists for contract or permanent roles. We build practical competence aligned to EU Annex 1 and site needs. Secure capability fast with your trusted partner.

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