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ABOUT us
- Swaroop Tech Services Pvt. Ltd came into existence in the year 1997 in Delhi, India. We are a strategic consulting and change management firm for the pharmaceutical and life sciences industry. We pride in announcing that we launched our very first software product (PRO-INVEST) this year.
- Initially, we started our operations by training scientists and engineers in the area of Process development with built-in quality, when the quality initiatives like TQM, TPM, and ISO-9000/1400, etc were at center stage in most of the organizations. Then we moved on to provide services and products for GMP implementation, regulatory approval, people development, and assessment. We specialize in Good Behavioural Practices, GBP, for the Pharmaceutical and life sciences industry.
- All the products in the industry should be of high quality and efficacy and we help build that quality into the process through Quality engineering practices and training. However, scientists and engineers were finding it difficult to implement the methods learned in the training programs. We recognized those challenges and found a solution by
- PRO-INVEST was a renowned and user-friendly menu-driven software designed for scientists and engineers with little to zero knowledge of software and computers. This software could be used easily after the training, in their day to day job.
- The main techniques introduced in this software were Factorial Design of Experiments, Fractional factorial Design of Experiments, Statistical analysis, process model building, and simulation for optimization of the process.
- Process Measurement gained a lot of importance in ISO. Moreover, the importance of Robust Process development was realized even in Six Sigma methodology and that’s when we launched another product CADROB in the year 2000 incorporating new features such as Process Measurement and Robust Process Development into the product. Further, to make it more versatile to run it on any platform, the software was upgraded and revised as SIGMA TECH in the year 2002.
- Since its inception in the year 1997, we’ve offered our software along with training and consultancy of projects and we have successfully marketed to Commercial Organizations, Academicians, and Professional Institutions in India as well as in Asia-Pacific regions. It has also helped under-graduate, graduate, and doctorate students in the completion of their projects and training with the help of these software packages. After the successful completion of the Research Projects, several papers were published in various International and National Journals.
- We at Swaroop Tech Services Pvt. Ltd launched its new product SIGMATECH 3.1 in 2006, incorporating most up to date features in the areas of quality standards as issued by ICH (International Council for Harmonization ) such as Q8 guidelines on pharmaceutical development, Q9 on quality risk management, and Q10 for the use of Quality Management( comprising of basically Regional GMP and ISO Quality System) with the concept of Quality by Design (QbD) to build the quality into the process and products right at the stage of process development. In June 2006, the FDA issued the same concepts in its Guidance for Regulated Industry like Pharmaceutical, Biological, Medical devices, etc. SIGMATECH 3.1 also has functionality and features such as Statistical analysis, Design Space, Simulation in Robust Methods, 21 CFR Part 11 Compliance, etc. Meet Our Fou
Meet Our Founder
Mr. Bhadrayya Kalva is the proud President and founder of Swaroop Tech Services Pvt. Ltd, a company that provides consultation and training in robust process design and product development for pharmaceutical, chemical and other organizations, including professional and educational institutions.
With experience of over 40 years in the pharmaceutical industry, he has worked in various capacities such as Chief Engineer, General Manager for a large pharmaceutical company IDPL (Indian Drugs & Pharmaceuticals Ltd). He has harnessed his rich experience in developing software for robust/ process design and product development namely Sigma Tech.
Professional Experience
- General Manager, Indian Drugs & Pharmaceutical Ltd (IDPL),
- Board of Director, Rajasthan Drugs & Pharmaceuticals Ltd.,
- Chief Engineer, Indian Drugs & Pharmaceutical Ltd (IDPL),
- Visiting Professor, BITS Pilani, INDIA,
- Visiting Professor, Management Development Institute, Gurgaon, INDIA.
Education
- Post Graduate Diploma in TQM and ISO-9000/ ISO-14000.
- Graduate in Industrial Engineering, Operations Research and Statistics.
- Graduate in Chemical Engineering
- Certification program in Six Sigma process development
Areas of Expertise
- Quality by Design (QbD), Design of Experiments (DOE), Process/product development to meet ICH Q8, ICH Q9 and ICH Q11 as recommended by FDA, Placket Burmann methods, Taguchi methods and Response Surface Methods, Robust Process Design with the help of Sigma Tech software for process design.
- Use of Quality Risk analysis to find out the CQAs (Critical Quality Attributes) from QTPP (Quality Target Product Profile), Risk assessment of CQAs vs UO/UP (Unit operations/ Unit Processes) and identifying high-risk operations, assessing the relationship between API attributes and CQAs, identifying control strategy, Establishing Design space, CPPS to obtain CQAs and Scale-up co-relations approach etc.
Professional membership
- Life Member, Quality Circle Forum of India.
- Life Member, Indian Institute of Chemical Engineers.
- Life Member, Indian Institute of Plant Engineers.
- Life Member, Indo French Technology Association.
- Fellow Ship Corporate Member, Indian Institution of Industrial Engineering.
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