RELIABLE REGULATORY PARTNER
FOR SMALL-MEDIUM BUSINESS
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
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.
Our dossier service facility Area is about 33,000 sft at APIIC, Madanapalle AP. We have most Advance and Sophisticated equipment.
HPLC used for Validation:- Shimadzu LC-2010
Format and Content : As per ICH / ASEAN / WHO / other country specific guideline
Products:- Pharma Formulation& Veterinary
We Provide AMV - Protocol, report with chromatograms
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.
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)
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
We are having own database (AMV -Assay, Disso and RS) - more than 300 Products
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
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Bangalore
PDDS
Zodiac Building, Third Floor, # 33, EWS, 8th Cross, Kengeri Satellite Town,
Bangalore, Karnataka,
PIN 560 060 India
Mumbai Office
Plot Number 78, SH Tower CHS, Jalvayu Rd, Sector 20, Kharghar, Navi Mumbai, Maharashtra 410210 India
Pragya Dossier-DMF Services
Plot No. 63, 76 & 77,
Industrial Park (APIIC) Valasapalli, NH 42 Madanapalle -517 325, AP, India
GSTN: 37AHNPT4410B1ZG
Email: info@pdds.in
Phone : +91 - 965 228 1814
Web: www.pdds.in
For Instant Quote:-
+91 - 965 228 1814 (whatsapp)
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