RELIABLE REGULATORY PARTNER
FOR SMALL-MEDIUM BUSINESS
Format : EU / WHO / Country specific guideline
BIOEQUIVALENCE STUDY:
We are allied with well recognized and reputed study centers which are approved from local regulatory body (DCGI) and other regulatory authorities (USFD, MHRA etc), to carry out BA / BE studies of various dosage forms.
We do:
BE Protocol Design and prepare BE report
Biostatics work and review of BE studies
Bioanalytical Protocol and report - Preparation and review
Biowaiver report - Preparation and review
We have experienced on more than 240 BE (US / EU)
We perform Comparative in vitro dissolution testing and also provide report. It can use in case of biowaiver.
Three major factors that govern the rate and extent of drug absorption from immediate release (IR) solid dosage forms are the dissolution of the drug product, and the aqueous solubility and intestinal permeability of the drug substance. The Biopharmaceutical Classification System (BCS) classifies the active substance into one of four classes, depending on the level of solubility and the level of permeability. Combination of the dissolution of the drug product with the BCS classification of the drug substance provides the possibility to waive in vivo bioequivalence studies for certain categories of IR drug products.
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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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