I will make method validation protocol with aqbd expertise
GMPfy: Pharma Documentation and Regulatory Support
About this Gig
At GMPfy, we offer expert support in Analytical Method Validation in full alignment with ICH Q2(R1), GMP, and AQbD guidelines.
With 17+ years of pharmaceutical experience and two peer-reviewed scientific publications (Journal of Pharmaceutical Research & Future Journal of Pharmaceutical Sciences) on AQbD-based method validation, our team ensures your methods are precise, reproducible, and inspection-ready.
Whether you require validation of an HPLC method, dissolution testing, or spectroscopic assay, we deliver a full package including protocols, statistical analysis, and validation summary reports all structured to meet regulatory requirements for the FDA, EMA, and WHO.
What You'll Get:
- ️Method Validation Protocol (ICH Q2-compliant)
- ️The report will cover accuracy, precision, specificity, LOD, LOQ, robustness, and system suitability. After you conduct the validation and share the data, well prepare the final report with interpretation and regulatory-compliant conclusions.
- ️ AQbD-based approach (Design of Experiments/DoE on request)
- ️ Supporting Excel/Statistical Tables
- ️ Editable DOCX + Print-ready PDF
- ️ Confidentiality and Regulatory Accuracy Guaranteed
Document type:
Documentation
•
Reports
Industry:
Other
Language:
English
Delivery style preference
Please inform the freelancer of any preferences or concerns regarding the use of AI tools in the completion and/or delivery of your order.
FAQ
Do you follow ICH guidelines for method validation?
Yes, we fully align with ICH Q2(R1) guidelines and incorporate AQbD principles when needed.
Can you prepare validation reports for HPLC or dissolution methods?
Absolutely. Our team has extensive hands-on experience in HPLC, UV-Vis, and dissolution method validation. After you conduct the validation and share the data, we’ll prepare the final report with interpretation and regulatory-compliant conclusions.
Do you offer AQbD-based validation designs (e.g., DoE)?
Yes, upon request, we can incorporate AQbD concepts like Design of Experiments and risk assessments.
Is my project information safe with you?
Absolutely. GMPfy ensures 100% confidentiality of all shared data and materials.
