1560 Holden Street San Diego, CA 92139

KING OF DOSSIER FOR INDIAN PHARMACEUTICALS PLAYERS

LARGEST TEAM AND QUICKEST DOSSIER PROVIDER, WE ASSURE FOR DELIEVARY OF DOSSIER EVERY THIRD DAY

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

Our Happy Clients

More than 230 Satisfied Global & Indian Clients