Qualxcl (Quality + Excellence) Technical Consultancy Services, a consultancy firm, formed under the Government of India company act in April 2018. The Bangalore based firm founded by Goutam Saha with an objective to provide sustainable, comprehensive consultancy support of Global standard at Indian cost to the Pharmaceutical, Biologics, Medical devices, Testing laboratories and the High-tech clean room manufacturing of Optical fibre, Aviation & Defence ordnances.

The founder is an Industry veteran with proven track of over 30-years in quality system, determining & deploying compliance strategy and an accomplished Leader in Design, Commissioning & Qualification, Documentation and Reverse engineering. Seen the transformation in quality system, regulatory demand and the challenges prevailing in the manufacturing industry in India, USA, China, Africa and Europe. Eventually, that deep rooted the passion and sincerity to deal with the technical & quality deficiencies in the industry and to support them for short and long-term resolutions.

This aptitude and acumen have augmented to form a scientific & quality Consultation support Partner firm as Quaxcl Technical Consultancy Services. We are endeavoured to excel high level of consistent technical, quality and regulatory services, teamed collaboratively by GxP experts and Engineers. The team members and associates are highly skilled, recognized in the Industry and baked rich with long standing practical experience.

Our core area of end to end hand holding support includes:

Gap analysis, SWOT analysis, Due-diligence audit; Business & Quality risk management as per CFR, EudraLex, ICH, ISO and WHO guidelines.

Coaching and training in GxP, Aseptic process, Engineering clean room, Quality system, Investigation, Data integrity, Computer system validation.

Investigation, RCA, CAPA and response of deficiency (483, audit finding, Warning letter, import alert etc) to the Regulatory bodies.

Qualification and Validation of Facility, Utilities and Equipment – risk based approach as per ASTM 2500E guideline.

Deployment and Up gradation of QMS, Cleaning validation, Process validation, and Deactivation validation.

Deployment of integrated vendor management system and Test laboratory quality management system.

Analytical method validation, transfer, development of product specification, OOT & OOS, SAL in Microbiology.

Conceptualize Lean Laboratory and Process Throughput Management (containment, platform technology).

Technical Documentation support – preparation, review and compliance verification as a part of Inspection readiness.

Recruitment of Technical staff, competency building. Strategies the Appraisal system, Behavioural aspect and Quality indices.

All time readiness audit preparation for WHO, MHRA, EMEA, INVIMA, ANVISA, TGA, PICs, US FDA, GCC, ISO 13485 (CE), ISO 17025 / NABL and ISO 9001.