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Pragya Dossier-DMF Services

RELIABLE REGULATORY PARTNER
FOR SMALL-MEDIUM BUSINESS

BIOEQUIVALENCE STUDY 

PDDS provides effective writing / reviewing the Bioequivalence Study as per WHO / Country specific guideline. Post sale, We provide cost-free support till product registration.

Email your BE requirements to info@pdds.in - We will review your requirements and revert back to you ASAP. And will also Quote /provide sample documents on demand

PREPARE, REVIEW AND SUBMIT 

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)

Comparative in vitro dissolution testing


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.

Procedure to order BE Service

Send Product name for which you need BE by email:- info@zodiacpharma.com

Our Team will review your BE requirement and Revert ASAP.

Our team will send quotation (price, delivery time and PSUR index for your approval)  



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Our Happy Clients

More than 150 Satisfied Global Clients

Address

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

Dossier Developing Unit 

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)