You will get Quality System GAP Analysis (ISO 9001 / GMP)
Project details
I will perform a complete GAP analysis of your Quality Management System according to ISO 9001, ISO 13485, and GMP standards. You’ll receive a detailed report highlighting nonconformities and an action plan to strengthen your QMS and achieve full compliance.
What's included
| Service Tiers |
Starter
$80
|
Standard
$140
|
Advanced
$200
|
|---|---|---|---|
| Delivery Time | 3 days | 5 days | 7 days |
Number of Revisions | 0 | 0 | 0 |
About Eduardo
Regulatory, Quality Consultant and Packaging Validation
Amparo, Brazil - 6:03 am local time
I’m a Regulatory and Quality consultant with a solid background in cosmetics, hygiene, and medical devices, helping companies ensure compliance with FDA, ANVISA, ISO, and GMP standards.
Over the past years, I’ve worked with multinational manufacturers in the hygiene and cosmetics sector, leading documentation and compliance projects that involved:
Preparation and submission of regulatory dossiers (ANVISA, INMETRO, FDA, IFRA, MoCRA)
Packaging validation, technical specifications, and stability testing
Conducting internal and external audits (ISO 9001, ISO 13485, ISO 14001, GMP)
Developing SOPs, CAPA reports, and risk assessments
Supporting product import/export and ensuring labeling compliance
My work bridges technical precision and regulatory insight, enabling faster approvals and reduced compliance risks.
What I deliver:
Regulatory and quality documentation review
GAP analysis for ISO or GMP systems
Packaging and labeling compliance validation
Audit readiness and CAPA support
Why clients choose me:
âś” Experience in international audits and cross-border projects (Brazil, Japan, Argentina)
âś” In-depth understanding of regulatory frameworks across LATAM, US, and EU markets
âś” Professional communication, clear deliverables, and on-time results
Let’s ensure your product meets every standard — and exceeds expectations.
Steps for completing your project
After purchasing the project, send requirements so Eduardo can start the project.
Delivery time starts when Eduardo receives requirements from you.
Eduardo works on your project following the steps below.
Revisions may occur after the delivery date.
Gap Analysis & Findings
I compare your system against ISO and GMP standards and list nonconformities.