About CLS
CLS Pvt. Ltd., was established in July 2019 with a vision to provide specialized analytical and research services for pharmaceuticals and medical device products with a mission to meet the customer expectations in terms of quality, delivery and cost. At CLS, we are committed to add value by offering need based pre & post support services to our customers in meeting their regulatory & research requirements.
CLS offers the following services
- Extractable&Leachable
- Method development & Validation
- Analytical Testing
- Pharmacopeia Compendial Testing
- Elemental Impurity Studies
- Raw Material & Excipient testing
- Genotoxic impurities evaluations (e.g. Nitrosamines, NDSRIs)
- Identification and quantification of degradation products
- Ethylene oxide sterilization residuals as per ISO 10993-7
- Unknown impurity profiling
- Packaging material and Ink Migration analysis
- Protein content test, Residual accelerator test etc
Technology
- LC-MS/MS (Shimadtzu-8060NX with Lab Solutions software)
- HSGC-MS/MS (Agilent 7000D with Mass Hunter software)
- ICP-MS (Agilent 7800 with Mass Hunter software)
- UV-Visible Spectrophotometer (Shimadzu Lab Solutions software)
- FTIR Spectrophotometer (Shimadzu Lab Solutions software)
- Soxhlet Extractor (Soxtron)
- Centrifuge (Eltek India)
- Microwave digester (Anton Paar)
- Nitrogen Evaporator (Eltek India)
- Autoclave (Servo Enterprisess)
- pH meter (Labman)
- Stability Chambers (1,000L capacity, complies to ICH conditions)
Location
CLS Private Limited is set up in two modules 313-314 at TICEL BIO Park-phase-1, 3rd Floor, No 5, CSIR Road, Taramani, Chennai-600113, India in a prime location with good common amenities and with round the clock CCTV surveillance and security. The facility is in located close to the airport and is well connected to main portions of the city.
Management
The facility is headed by Dr. Philip Ashok Karunakaran who is the Co-Founder, Director. He holds a PhD in Pharmaceutical quality Management and has been in the pharmaceutical field for almost 3 decades with a proven track record of supporting companies in realising it’s goals and building successful teams. He has held senior Management positions in companies of repute and has played significant roles throughout his career.
Technical and Quality assurance teams are led by experienced Managers who have more than a decade of experience in the field of trace analysis and in Mass Spectrophotometric techniques.