About CLL»
Established in 1982, Choksi Laboratories Limited (CLL), is a leading Contract Research Organization with five branch laboratories across India. CLL provides complete solutions for improving quality in your products, services and processes.
- CLL’s process quality solutions encompass calibration and validation of production & quality control equipment with traceability to national / international standards through ISO/IEC accredited laboratories. Accurate and precise instrumentation yield more controlled processes thereby reducing the probability of end-product defects / rejects.
- CLL also provides risk-assessment services to identify and measure risk associated with your processes, and devise innovative control measures to mitigate the risks. Such risk assessments are routinely carried out for Food (HACCP / FSSC : 22000) and Pharmaceutical manufacturers (Nitrosamines / Elemental impurities etc.).
- CLL laboratories provide research and quality control services for a wide spectrum of products and materials – pharmaceutical raw materials and formulations, agro products and their derivatives, disinfectants / sanitizers, fertilizers, pesticides & agrochemicals, edible and industrial oils, chemicals, paints and dyes, toys, construction materials etc.
- A vast constantly updated database of test specifications and methods are available with CLL such as APHA, AOAC, AACC, EPA, USP, BP, CP, EP (EDQM), IP, IS (BIS), EPA, FSSAI, Food Chemicals Codex, AOCS, and several in-house methods.
- Implementation of ISO 900x (Quality Mgt. Systems), ISO 14000, ISO/IEC 17025, GxP, HACCP etc., involves strict time-bound schedules, and very often, setting up in-house Quality Control labs. This requires a detailed knowledge of the industry sector as well as the client’s business processes.
- CLL has expertise in setting up in-house labs for a large number of clients. We also provide consultancy, training & independent inspection and auditing for Quality Mgt. Systems.
- Our quality assurance solutions address almost every aspect of regulatory norms set by FDA, BIS, NABL (National Accreditation Board for testing & calibration Laboratories), Department of Health and other regulatory bodies.
R&D
- Characterization
- Impurity Identification & Synthesis
- WHO BCS Classification
- Reverse engineering
- In-vitro Cytotoxicity evaluation
- ICH M7 Impurity risk assessment & report
- In-vitro Biowaiver studies
Market Surveillance
- Stability Studies
- NDSRIs / Genotoxic impurities Assessment & Evaluation
- OOS / OOT investigations
- Market complaints investigation
- Vendor (Re-) Qualification
- Recall / Alert assistance
- Risk assessment
Quality Control
- Batch Analysis for Raw Materials, Drug Substances and products.
- Dietary Supplements
- Neutraceuticals analysis
- FSSAI compliance
- Vaccines
- Medical Devices
- AYUSH
Product Development
- Analytical Method Development
- Validation
- Tech-Transfer
- Extractable & Leachable Studies
- STP and Specification Development
- Forced Degradation
- G/NG tube studies
Training
- Data integrity & Ethics
- GDP / GLP
- ISO/IEC 17025
- 21 CFR Part 11
- CSV
- 21 CFR Part 210/211
- GWP & GTP
- Technique specific training
