You will get Clinical Trial QA & GCP Compliance Review: Audits, CAPA & SOP Support
Top Rated
Project details
I help clinical trial teams stay inspection-ready, compliant, and efficient by providing senior-level GCP Quality Assurance support. With more than 20 years of QA and compliance experience in global pharmaceutical environments, I specialize in auditing study documentation, ensuring regulatory alignment (ICH-GCP, FDA, EMA), strengthening QMS workflows (including ZenQMS), and identifying risks before they become findings.
You will receive a clear, structured, and actionable QA assessment that improves documentation integrity, enhances operational quality, and prepares your team for sponsor audits, monitoring visits, or regulatory inspections. My approach is proactive, detail-oriented, and focused on helping you maintain a high-quality clinical trial throughout its entire lifecycle.
Whether you need support with audit preparation, documentation review, deviation/CAPA analysis, TMF/ISF consistency checks, or QMS optimization, I deliver work that is fast, accurate, and aligned to the highest GCP standards.
You will receive a clear, structured, and actionable QA assessment that improves documentation integrity, enhances operational quality, and prepares your team for sponsor audits, monitoring visits, or regulatory inspections. My approach is proactive, detail-oriented, and focused on helping you maintain a high-quality clinical trial throughout its entire lifecycle.
Whether you need support with audit preparation, documentation review, deviation/CAPA analysis, TMF/ISF consistency checks, or QMS optimization, I deliver work that is fast, accurate, and aligned to the highest GCP standards.
Project Type
Business Consulting, Training & DevelopmentWhat's included
| Service Tiers |
Starter
$95
|
Standard
$350
|
Advanced
$850
|
|---|---|---|---|
| Delivery Time | 2 days | 4 days | 7 days |
Number of Revisions | 1 | 2 | 2 |
Optional add-ons
You can add these on the next page.
Fast Delivery
+$45 - $250
Additional Revision
+$35
CAPA Deep-Dive Investigation
(+ 2 Days)
+$120
SOP Creation or Update (1 SOP)
(+ 2 Days)
+$90
TMF Quality Review (20 Files)
(+ 2 Days)
+$140Frequently 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 - 1:06 pm 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.
Document Intake & Regulatory Alignment
i review all study documents (protocol, ICFs, logs, reports, SOPs) and confirm alignment with ICH-GCP, FDA/EMA requirements, and your internal QMS/ZenQMS structure.
GCP Compliance & Documentation Review
I perform a detailed assessment of documentation integrity (ALCOA+), version control, protocol adherence, training completeness, and risk areas across study files.