Protect Your Cosmetic Brand.
Get HPRA Ready in 30 Days, Guaranteed.
Your complete HPRA compliant cosmetic Quality Management System built, deployed and executed in just 30 days.
Instant access. Full support. No guesswork.
3 Outstanding Benefits of our Cosmetic Compliance Program
Tailored HPRA ready Quality Management System in 30 days.
All the document templates you need for an audit ready Quality System.
Expert support through the program to rapidly increase compliance.
Who This is Program For?
Our 30-Day Cosmetic Compliance Program can help if this is you:
The Problem
Cosmetic companies with regulatory observations or facing a HPRA regulatory audit with weak CPSRs, PIFs and quality management system.
The Person
Influencer brands, Managing Directors, and Responsible Persons that want to take a proactive approach to cosmetic regulations.
The Timeline
Cosmetic companies with recent observations or an upcoming HPRA audit and needing day rapid remediation within a 30 day timeframe.
The Modality
This program is solely focused on cosmetic compliance in accordance with EC 1223/2009, ISO 22716 and HPRA Cosmetic guidelines.
The Bandwidth
Cosmetics companies committed to quality but lacking regulatory experience or bandwidth and needing compliant and audit-ready results fast.
What You Get – Day 1 Access
Everything you need to respond with confidence, avoid escalation, and restock products:
HPRA Response Pack
Complete, structured response letter with root cause tools and CAPA tracker. Built to HPRA expectations. Saves time, avoids escalation, and puts you in control from Day 1.
EMA-Compliant Quality Updates
​SOPs, policies, protocols, validation templates, and QMS links. All pre-formatted, ISO 22716 and EC 1223/2009 aligned. Removes ambiguity and ensures your system can withstand regulatory scrutiny.
Expert Support (All 30 Days)
Direct access to Pharmalliance GMP specialists by email and video. Includes Day 1 kickoff, daily check-ins, and optional 1:1 review to guide your team through execution.
Risk Assessment Toolkit
​Rapid tools to identify, prioritise and map GMP cosmetic compliance risks. Includes facility flow maps, risk matrices, and cleanroom failure libraries to get instant visibility and action alignment.
CPSR / PIF / CPNP Compliance
Expert reviews of your Cosmetic Product Safety Reports (CPSRs), Product Information Files (PIFs) and Cosmetic Product Notification Portal (CPNP) submissions, identifying gaps and ensuring compliance.
Audit-Ready Documentation
​Instant access to SOPs, dashboards, walkthrough decks, and inspection Q&A binders. Every tool formatted for inspection use — no guesswork, just results you can present confidently.
Corporate Quality Plan
Fully developed remediation roadmap linked to CAPAs, timelines, owners and QA sign-off. Structured for executive review and ready for submission to regulators within 7 days.
CPD-Certified Training Program
Ready-to-deploy GMP and cosmetic fundamental modules for QA, RP and Supply Chain. SCORM-compatible and audit-ready with assessments, training matrix, and certification for inspection evidence.
Bonus Compliance Tools
​Includes 30+ SOPs, FDA 483 examples, audit checklists, risk assessments, 100 licenses for CPD training, and CCS templates. Value of €50k — all included with your site license at no extra cost.
30-Day Execution Plan
HPRA Response Pack
You Get:
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HPRA Response Letter Template (regulatory language + CAPA structure)
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Root Cause Analysis Tools: 5-Why, Fishbone, Human Error
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CAPA Tracker (with risk ranking, owners & due dates)
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Executive Brief: “What This Means” deck for internal alignment
CPSR / PIF / CPNP Compliance
You Get:
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CPSR Master Template (ISO 22716 aligned)
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Expert reviews of your Cosmetic Product Safety Reports (CPSRs),
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Product Information Files (PIFs) and
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Cosmetic Product Notification Portal (CPNP) submissions for compliance
Risk Identification / Gap Analysis
You Get:
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Facility Risk Map (people, product, air, waste)
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GxP Process Criticality Matrix
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ISO 22716 and EC 1223/2009 Gap Mapper
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Environmental Monitoring and Utilities Risk Tools
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FMEA Templates (pre-populated for cleanrooms and equipment)
Training & Behaviour Change
You Get:
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CPD-Certified Training: GMP Fundamentals, Contamination Control Excellence Program
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35 Microlearning Modules (24/7, online and SCORM-ready)
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Training Matrix + Role-Based Modules
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Operator Training Assessments + Audit-Ready Records
Corporate Remediation Plan
You Get:
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Corporate-Level Remediation Strategy (HPRA audit-proof format)
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SOP Gap Identifier Tool (auto cross-check vs regs)
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Risk-Based Implementation Plan (linked to CAPAs) ready for FDA submission
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RACI Matrix for Quality, Engineering, Operations
Inspection Readiness Pack
You Get:
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Finalised Response Letter + Supporting Documents
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Inspection Walkthrough Deck (10-slide format)
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​HPRA Reference Binder (with model answers)
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SOP-to-Reg Clause Mapping Tool
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Mock Inspection Readiness Checklist
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. ”
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
Remediation should not be confined to a select few individuals. For lasting change the whole site gets access to our CPD Certified material for 1 year post purchase.
Some of our happy clients
