QbD Research & Development Lab Pvt Ltd

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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

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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.
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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

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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.

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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.

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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.

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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

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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.

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QMS in Place from Inception

• Site Master File.
• Standard Operating procedures.
• Formats.
• Work Instructions.
• Periodic Training with Documentation.

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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.

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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

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Stability Chambers

• Stability chambers from Mack Pharma with 3000
  liters of capacity 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.

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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.

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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.

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Partial Client List

• Adisan
• Arch Pharmalabs
• Aarti Drugs
• Ajanta Pharma
• Apicore
• Crown Labs - USA
• Encube Ethicals
• Elder Pharma
• Gangwal Chemicals Pvt. Ltd.
• Glenmark
• GHPL
• Lupin
• Om Pharma
• V Ensure

• Puerto Rico Pharmaceutical
• Piramal Enterprises Limited
• PellTech Healthcare
• Rank Organic
• RD2RX - USA
• SRS Pharma
• Receta Pharma
• RPG Life Sciences
• Sanmour Pharma
• Siemens
• ThinQ Pharma
• Sydler Remedies
• Stantech
• USV
• Zim Laboratories

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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

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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_at_qbdresearch.com
• URL http//qbdresearch.com