QbD Research & Development Lab Pvt Ltd

1. 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

2. Company founded by Mr. NileshDhamorikar Responsible for day to day operations of the company. Mr. Shrikant Kulkarni looks after Admin, Systems and Finance.Dr. ShirishSahasrabudhe heads Marketing and Business Development.

3. 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

4. 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.

5. 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.

6. Personnel • People are the key for us. • Handpicked personnel with technical expertise. • Continuous training to inculcate Organization’s commitment towards Quality and client requirements. • Road Map for career growth for all personnel.

7. 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

8. 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 7.2CDS • Auditable Lab. • For us the “Process” is as important as the Result. • Defined procedure to evaluate customer satisfaction.

9. QMS in Place from Inception • Site Master File. • Standard Operating procedures. • Formats. • Work Instructions. • Periodic Training with Documentation.

10. 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.

11. Instruments • AB – SCIEX API 2000 LC – MS – MS • Impurity Profiling • Extractable and leachable testing • De -formulation studies • HPLC’s 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

12. 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.

13. 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.

14. 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.

15. Partial Client List • Adisan • Arch Pharmalabs • Aarti Drugs • Ajanta Pharma • Apicore • Crown Labs - USA • EncubeEthicals • 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

16. 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

17. 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