Who Is The cGMP Remediation Expert Network For?
If any of these sound familiar, our network of remediation experts is here to help:
The Problem
Sites that are struggling with cGMP compliance issues driven by regulatory inspections for their manufacturing facility.
The Person
Quality Directors, Compliance Leads, and Site Heads that want to take a proactive approach to hiring the best talent.
The Timeline
Sites that are under pressure to hire, train and onboard Contamination Control Specialists in 14 days or less.
The Modality
Sterile, Non-Sterile, ATMP, or OSD or API facilities that are seeking the best talent globally to increase compliance.
The Bandwidth
Teams committed to quality but lacking bandwidth and needing dedicated, qualified and results driven personnel fast.
Why Choose Us?
Everything you need to remediate with confidence:
GMP Experts
Our cGMP experts specialise in FDA, EMA, PIC/S regulation remediation project. They have hands on remediation experience in high pressure situations.
Zero Onboarding Time
Our people are job-ready on arrival. No need for internal GMP refreshers, cleanroom behaviour coaching, or Annex 1 briefings, we deliver fully prepared, site-ready professionals.
Fast Global Deployment
We can place fully trained cGMP Remediation Specialists into your cGMP manufacturing facility anywhere in the world within 7–14 days, eliminating recruitment and onboarding delays.
Flexible Engagement Models
We offer contract, permanent, or contract-to-perm solutions to match your operational model. Start small and scale fast with total flexibility and full quality oversight included.
cGMP Remediation Focus
This is not a generalist QA pool. Every individual is selected and trained specifically to drive cGMP remediation projects in sterile and non-sterile manufacturing environments.
Built by Industry Experts
The network is designed and operated by pharmaceutical cGMP remediation leaders with over 20 years’ experience delivering compliance in FDA, EU, and TGA-regulated facilities.
14-Day Execution Plan — One Clear Deliverable Per Day
Discovery & Scope
Day 1-2:
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Conduct a discovery call with your QA or Site Lead
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Define role type: contract, permanent, or contract-to-perm
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Confirm key pain points (Annex 1 prep, EM issues, cleanroom behaviour, etc.)
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Lock in timeline, site location, and expectations
Contracting & Site Readiness
Day 8-9:
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Issue and sign all necessary agreements (services, NDA, access forms)
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Align on site-specific requirements (induction, PPE, travel, access)
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Confirm deployment date and logistics
Candidate Match or Rapid Sourcing
Day 3-5:
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Search existing pool of experienced cGMP remediation expers
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If needed, initiate sourcing and fast-track onboarding for new candidates
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Share top candidate profiles for client review
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Confirm shortlisting for interview
Pre-Deployment Briefing
Day 10-12:
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Deliver client-specific cGMP Remediation briefing
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Validate readiness using a Pharmalliance checklist (Annex 1, EM, gowning, etc.)
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Provide tools/templates if needed
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Final logistics confirmed
Interview & Selection
Day 6-7:
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Facilitate technical interview between client and candidate online or in person
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Address contamination control scenarios and site-specific expectations
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Final team selection presented by Pharmalliance
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Begin onboarding preparation for selected candidate
On-Site Start & Support
Day 13-14:
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Specialist arrives on-site or completes virtual onboarding
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Immediate contribution to site operation
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Check-in with client on Day 14 to confirm satisfaction
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Ongoing Project Management support from Pharmalliance
Testimonials
QA Lead, Sterile Operation
“Pharmalliance delivered exactly what we needed – fast, relevant, and high-quality Aseptic Fundamental training tailored to our sterile ophthalmic remediation project. "
Executive Project Lead, OSD
"Their team’s real-time oversight and deep compliance knowledge were critical in improving documentation (ALCOA) and reducing deviations and aligning us with EU GMP expectations."
QA Manager, Sterile OTC
“We faced numerous technical challenges, but their service delivered brilliant solutions. Their hands-on approach meant we felt supported throughout the project. ”
Our Experts Are Qualified and Trained
Each expert get exclusive access to our expert network, regulatory playbooks, documentation libraries, and CPD Certified training material:
Included Bonuses
1
Internal Audit Toolkit
We provide all the templates that you need to identify your cGMP / Annex 1, and Microbial Control risks. These risks are assigned a Risk Priority Number (RPN) and linked to CAPA's.
2
CPD Training Modules
Our CPD Certified cGMP Fundamental and Contamination Control Program elevate your sites knowledge and compliance level quickly. These training programs are available 24/7.
3
Full Site Access
CPD Certified cGMP training modules are not be confined to our experts. For lasting quality culture change the whole site gets access to our CPD Certified material for 1 year post project.
Some of our happy clients
Time is Critical and The Time for Action is Now.
Join Our cGMP Remediation Expert Network Today!
cGMP Remediation Specialists.
Global Deployment.
Immediate Impact.
We have a curated network of cGMP remediation experts with senior level experience navigating regulatory compliance issues, that can be deployed globally in as little as 7 days.