You will get FDA & EMA Document Review, Compliance Fixes: SOPs, CAPA, Deviations, Audit
Top Rated
Project details
I provide expert FDA & EMA, aligned document review and compliance fixes for pharmaceutical, biotech, medical device, and GxP-regulated organizations.
With over 20 years of hands-on experience in multinational GMP environments (Bayer, MSD, Abbott, mAbxience), I help teams correct compliance gaps, strengthen documentation, and ensure audit-ready quality systems.
Your project will include clear, actionable improvements to SOPs, CAPAs, deviations, validation deliverables, or audit responses, always referencing 21 CFR 210/211, 820, Part 11, EMA Annex 11, QMS expectations, and GAMP 5 where applicable.
My goal is simple: deliver high-quality, inspection-ready documentation that reduces regulatory risk and elevates your overall Quality System. Every recommendation is practical, technically sound, and aligned with real-world regulatory expectations.
With over 20 years of hands-on experience in multinational GMP environments (Bayer, MSD, Abbott, mAbxience), I help teams correct compliance gaps, strengthen documentation, and ensure audit-ready quality systems.
Your project will include clear, actionable improvements to SOPs, CAPAs, deviations, validation deliverables, or audit responses, always referencing 21 CFR 210/211, 820, Part 11, EMA Annex 11, QMS expectations, and GAMP 5 where applicable.
My goal is simple: deliver high-quality, inspection-ready documentation that reduces regulatory risk and elevates your overall Quality System. Every recommendation is practical, technically sound, and aligned with real-world regulatory expectations.
Project Type
Business Consulting, Legal, Training & DevelopmentWhat's included
| Service Tiers |
Starter
$95
|
Standard
$295
|
Advanced
$595
|
|---|---|---|---|
| Delivery Time | 2 days | 5 days | 9 days |
Number of Revisions | 0 | 1 | 2 |
Optional add-ons
You can add these on the next page.
Fast Delivery
+$40 - $100
Additional Revision
+$45Frequently asked questions
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GA
Gal A.
Mar 27, 2026
MHRA Medical Device Technical File + Registration Expert Needed (UK)
About Efrain
FDA / EU MDR Regulatory & eQMS Consultant | Pharma, MedTech, SaMD & AI
100%
Job Success
Argentina, Argentina - 9:05 am local time
My work focuses on translating regulatory frameworks: FDA, EMA, MHRA, EU MDR and global GMP, into practical, operational systems including QMS architecture, eQMS implementation, audit readiness programs, technical documentation structures and compliance strategies.
I typically support companies in situations such as:
• Preparing for FDA, EMA or MHRA inspections and audits
• Building or remediating Quality Management Systems (QMS / eQMS)
• Developing regulatory documentation and technical files for medical devices and SaMD
• Strengthening compliance infrastructure for global market expansion
Clients engage me when regulatory complexity becomes a strategic barrier to growth.
Steps for completing your project
After purchasing the project, send requirements so Efrain can start the project.
Delivery time starts when Efrain receives requirements from you.
Efrain works on your project following the steps below.
Revisions may occur after the delivery date.
Kickoff & Document Intake
I request access to your SOPs, CAPAs, deviations, forms, and any relevant system context. This ensures the assessment aligns with FDA 21 CFR Part 11, 210/211, 820 and EMA Annex 11 expectations from the very beginning.
Regulatory & QMS Compliance Review
I review your documents to identify gaps, missing controls, inconsistencies, or audit-critical risks. All findings are clearly and professionally documented to support audits, inspections, or corrective actions.