QbD Research and Development

Lab Pvt. Ltd.

Address : 2nd Floor, TISSIA HOUSE,

Road No. 16/T, Wagle Industrial Estate,
Opposite, Caprihans India Limited,
Thane (W) 400604,Maharashtra, INDIA
 Company founded by
Mr. Nilesh Dhamorikar Responsible for day to day
operations of the company.

Mr. Shrikant Kulkarni looks after Admin, Systems and

Finance.

Dr. Shirish Sahasrabudhe heads Marketing and Business

Development.
 Genesis
Company Incorporated in June 2012
Lab operational in November 2012
Indian FDA approval in February 2013.
USFDA FEI Number received in Sept 2013
NABL accredited in Feb 2016
Audited by USFDA in Feb 2016
EIR received in Nov 2016
 Vision

To be the Trusted Lab for :

Analytical Method Development.
Analytical Method Validation.
Stability Testing.
To be a simple and truthful organization having trust of
its clientele and regulators.
 Mission

To adopt best in industry practices to offer solutions to

customer problems.
Instill values in the staff members to build an honest and
dedicated organization focused on customer satisfaction.
To strive to accept challenges in the field of analytical
services.
Use latest technology to achieve customer satisfaction
with regulatory compliance.
 Personnel

People are the key for us.

Handpicked personnel with technical expertise.
Continuous
training to inculcate Organizations
commitment towards Quality and client
requirements.
Road Map for career growth for all personnel.
 Key Competencies

Analytical Method Development on HPLC and GC and Dissolution Testers

Method Validation

Stability Testing

Compendial Testing

Comparative Dissolution Testing

Impurity Profiling and characterization on LC MS - MS

 Commitment towards quality
Committed to uphold utmost standards of Quality across all our
systems and processes.
Trained team to make quality inherent at each step.
All instruments with IQ, OQ, PQ.
Documented evidence of quality.
Bound notebooks and logbooks for entry of raw data.
CFR21 Part 11 Compliant Instruments on Chromeleone 7.2 CDS
Auditable Lab.
For us the Process is as important as the Result.
Defined procedure to evaluate customer satisfaction.
 QMS in Place from Inception
Site Master File.

Standard Operating procedures.

Formats.

Work Instructions.

Periodic Training with Documentation.

 Infrastructure
Easily accessible location in Thane.
Well Designed lab in secured premises.
Power from two feeder lines reducing chances of power outage.
Premises to has solar power as additional back up by May 2013.
All instruments and utilities on Emerson UPS.
Round the clock Security.
Pest Control for the facility.
Fire Safety.
Maintenance of Highest EHS standards for personnel.
Secure Electronic Data Storage and Back up.
 Instruments

AB SCIEX API 2000 LC MS MS

Impurity Profiling
Extractable and leachable testing
De -formulation studies
HPLCs from Agilent and Shimadzu and Thermo
GC HS ALS from Agilent and Thermo
UV VIS and FTIR from Agilent
Balances from Mettler Toledo ranging from ultra-microbalance to
Analytical Balances
Fully automated Dissolution testers from Lab India
Disintegration tester and Automated KF Titrator from lab India
AB SCIEX API 2000 LC MS - MS
 Stability Chambers

Stability chambers from Mack Pharma with 3000

liters ofcapacity for storing samples for stability
testing.
Chambers with a compliant data acquisition and
monitoring software.
The chambers are equipped with standby systems
like compressors and heaters with automatic
changeover facility in case of failure.
 Key competencies

Dissolution Method Development and Validation.

Residual Solvent Method Development and Validation.
HPLC method development and Validation.
Stability Analysis with Tracking and Trending.
Analysis on Agilent HPLC with RI Detector.
De-formulation Studies.
Impurity profiling on LC MS MS.
Genotoxic impurity validations on LC MS MS.
 Types of Formulations Handled
All oral dosage forms for Assay , Impurity, Release
Profile and Residual Solvent tests.
Topical formulations for Release Profile on USP Type V
and VI Dissolution Testers.
Injectables for chemical analysis.
Suppositories for release testing and chemical
analysis.
Viscosity Testing on Brookfield Viscometer with
Hellipath stand T shaped spindles.
 Partial Client List
Puerto Rico Pharmaceutical
Adisan
Piramal Enterprises Limited
Arch Pharmalabs
PellTech Healthcare
Aarti Drugs
Rank Organic
Ajanta Pharma
RD2RX - USA
Apicore
SRS Pharma
Crown Labs - USA
Receta Pharma
Encube Ethicals
RPG Life Sciences
Elder Pharma
Sanmour Pharma
Gangwal Chemicals Pvt. Ltd.
Siemens
Glenmark
ThinQ Pharma
GHPL Sydler Remedies
Lupin Stantech
Om Pharma USV
V Ensure Zim Laboratories
 Accreditations

Indian FDA approval received in 2013

USFDA has audited the lab in Feb 2016 and EIR received
Lab is NABL Accredited
FDA FEI Number : 3006121542
 Contact Us

QbD Research and Development Lab Pvt. Ltd.

Phone - +91 9820039113; +91-22-25839113
Address: 2nd Floor, TSSIA House, Plot No. P 26,
Road No. 16 / T, Wagle Industrial Estate,
Thane(W) 400604.
Email lab@qbdresearch.com
URL: http://qbdresearch.com