You will get I will write sops for gmp, glp, iso 17025, quality systems
Project details
I provide professional GMP, GLP and ISO 17025 consulting with a strong background in pharmaceutical quality control and laboratory compliance. I help companies build, improve or prepare their quality systems for audits and inspections through practical, step-by-step solutions.
My service focuses on real implementation — not theory — including SOP development, internal audits, mock inspections and staff training. Each project is customized to your operations, ensuring full regulatory compliance and inspection readiness.
If you need a clear, reliable and audit-focused approach, this project is designed for you.
My service focuses on real implementation — not theory — including SOP development, internal audits, mock inspections and staff training. Each project is customized to your operations, ensuring full regulatory compliance and inspection readiness.
If you need a clear, reliable and audit-focused approach, this project is designed for you.
Project Type
Business ConsultingWhat's included
| Service Tiers |
Starter
$30
|
Standard
$120
|
Advanced
$240
|
|---|---|---|---|
| Delivery Time | 3 days | 7 days | 12 days |
Number of Revisions | 0 | 0 | 0 |
About Zge
M.Sc Chemical Engineer
Istanbul, Turkey - 4:35 am local time
Hello! I’m Özge Düzgün, a Chemical Engineer (M.Sc.) with over 8 years of hands-on experience in pharmaceutical, cosmetic, food supplement, and chemical laboratories.
I specialize in analytical method validation, regulatory documentation, and GMP/GLP compliance.
My expertise includes:
- Analytical Method Development & Validation:
HPLC / GC / UV-Vis method setup and validation according to ICH Q2(R1), FDA, and EU GMP Annex 15.
Process, cleaning, and analytical technology transfer validations (ICH Q7–Q11, FDA 21 CFR Part 211).
Preparation of validation protocols, reports, and SOPs.
-Regulatory Affairs & Licensing:
Preparation of CTD files, Product Information Files (PIF), and technical dossiers.
Experience with pharmaceutical (T.C. MoH, EMA, FDA), biocidal (BPR, EPA), and cosmetic (CPNP, Turkish Cosmetics Regulation) registrations and notifications.
Regulatory risk assessments (FMEA, HACCP).
- Quality & Compliance:
GMP/GLP laboratory setup consulting, internal audits, and documentation standardization.
Data review, report preparation, and method optimization according to ISO/IEC 17025.
During my master’s research, I developed and validated a new HPLC method for determining coumarin in Helichrysum arenarium (Immortelle), demonstrating my ability to build innovative, compliant analytical methods from the ground up.
If you’re looking for a reliable, detail-oriented professional who can combine scientific expertise with regulatory precision, I’d be happy to help your business meet international standards.
Steps for completing your project
After purchasing the project, send requirements so Zge can start the project.
Delivery time starts when Zge receives requirements from you.
Zge works on your project following the steps below.
Revisions may occur after the delivery date.
1
Customer information is reviewed. Based on this information, the project scope, applicable standards (GMP, GLP, ISO 17025), and objectives are determined.
2
By analyzing existing processes and documents, deficiencies in regulatory compliance are identified.