// Qdot Association


Qdot Associates’s engagement of its clients is underscored by the motive of “Companion for Quality”;This is achieved through designing for sustainable improvements and beyond the services and deliverable(s); This is attained by taking an holistic and long term view of the “Designing for compliance” and at the same time with an life cycle approach towards defining systems; the follow through implementation steps assures the sustainability, through aligning the ‘processes’ and ‘personnel’, leading to “Compliance by Design”. Doing this efficiently and effectively in shorter turn-around-times makes it most suitable for prevention and resolution of immediate compliance problems; and time bound remediation activities in a systematic and timely manner. Ability to Integrate the investigation tools and techniques with the engagement of shop-floor& bench-level personnel as well was manager will always leads to effective CAPA, in turn creating an participating and sustainable compliance. Qdot Associates is built on professional experience of subject matter experts with 20+ years of experience of handling multiple regulatory authorities, across dosage forms throughout the product life cycle. ( starting from development to manufacturing and commercialization).
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What we delivered

ClientsWhat we doMile stones achieved
Encube Ethicals- Goa (Asia’s larget semisolid manufacturing facility)
  • Review of Investigations/ guidance
  • Improvements in productivity
  • Remediation plan for two 483s (inadequate investigations, storage of standards)
  • Zero 483’s in Nov 2018 inspection
  • EIR received based on the remediation proposed.
Encube Ethicals- Mumbai (Development center with all advanced instruments)
  • Review of Investigations/ guidance
  • Qbd based method/ process development and validation
  • Zero 483’s in Feb 2019 inspection
Daicel (Chiral) Technologies Ltd (leader in chiral technology, Analytical services, impurity synthesis and characterization)
  • Review of Investigations/ guidance
  • Setting up the procedures for batch release, stability testing
  • Training to the team members
  • Zero 483’s in Mar 2019 inspection
Qbd Research Labs (Analytical services, Extractable & Leachable studies)
  • Review of Investigations/ guidance
  • Setting up the procedures for batch release, stability testing
  • Training to the team members
  • Expecting the inspection in the month of March 2020

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Whom we are working with

ClientsWhat we doMile stones achieved
Mythri Labs- API manufcaturer Review of Investigations/ guidance Gap assessment for USFDA inspection Inspection completed one observation pertaining to process validation.
Beximco- manufacturing facility at Bangladesh Worked for the gap assessment at the R&D laboratory Report submitted
Sierra labs- New manufacturing setting up at Newjersy
  • Setting up the procedures for the pilot manufacturing facility
  • Setting up the procedures for analytical services
Project initiated on Jan 2020.
Chromcore laboartories- New laboratory for inhalation product analysis
  • Review of Investigations/ guidance, Gap assessment for EU/ USFDA inspection.
  • Target for the inspection in next 4 to 6 months time
Granules India Limited (API & FP Manufacturer ) Review of Investigations/ guidance, Training to the team members Enhancing the level of investigations.
Biocon (Asia’s premier biopharmaceutical company) Productivity Improvements in QC laboratory, Optimizing the SOPs in the R&D laboratory, Setting up/ enhancing the quality overview at R&D, Review of Investigations/ guidance, Review of ANDAs before submission
Suven life sciences ( Contract Research And Manufacturing Services ) Review of Investigations/ guidance Enhancing the level of investigation through rubric score