Analytical Method Validation
Fides Regulatory provides Analytical Method Validation of API & Formulation Product . Post AMV sale, We provide free support till product registration.
Email your AMV requirements to dhaarmi@fidesregulatory.com/ fidesraa@gmail.com - We will review your requirements and revert back to you ASAP. And will also provide sample documents on demand.
ANALYTICAL METHOD VALIDATION
Format and Content : As per ICH / ASEAN / WHO / other country specific guideline
Products:- Pharma Formulation, Bulk (API) & Veterinary
We Provide AMV - Protocol, report with chromatograms
Accuracy
Precision
Repeatability
Intermediate Precision
Specificity
Detection Limit
Quantitation Limit
Linearity
Range
ANALYTICAL METHOD VERIFICATION
Format and Content : As per country specific guideline
Products:- Pharma Formulation, Bulk (API) & Veterinary
We Provide AMV - Protocol, report with chromatograms
Its required when Drug product / API is Pharmacopoeial.
IN-HOUSE ANALYTICAL RESEARCH LAB
Our dossier service facility Area is about 4500 feet. We have most Advance and Sophisticated equipment
HPLC used for Validation:- Shimadzu LC-2010
ANALYTICAL METHOD VALIDATION
Format and Content : As per ICH / ASEAN / WHO / other country specific guideline
Products:- Pharma Formulation& Veterinary
We Provide AMV - Protocol, report with chromatograms
ANALYTICAL METHOD VERIFICATION
Format and Content : As per country specific guideline
Products:- Pharma Formulation & Veterinary
We Provide AMV - Protocol, report with chromatograms
Its required when Drug product is Pharmacopoeial.
IN-HOUSE ANALYTICAL RESEARCH LAB
Our dossier service facility Area is about 30,000 sft at APIIC, Madanapalle AP. We have most Advance and Sophisticated equipment.
HPLC used for Validation:- Shimadzu LC-2010
Dissolution System (Labindia)
ANALYTICAL METHOD VALIDATION
Format and Content : As per ICH / ASEAN / WHO / other country specific guideline
Products:- Pharma Formulation and Bulk (API)
We Provide AMV - Protocol, report with chromatograms
ANALYTICAL METHOD DATABASE
We are having own database (AMV -Assay, Disso and RS) - more than 300 Products
IN-HOUSE ANALYTICAL RESEARCH LAB
Our dossier service facility Area is about 30,000 sft at APIIC, Madanapalle AP. We have most Advance and Sophisticated equipment.
HPLC used for Validation:- Shimadzu LC-2010
