Qualxcl (Quality + Excellence) Technical Consultancy Services, a consultancy farm, formed under the Government of India company act in April 2018. The Bangalore based farm is founded by Goutam S 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 fiber, Aviation & Defence ordnances.
Seen the transformation in quality system, regulatory demand and the challenges prevailing in the manufacturing industry in India, USA, China, Kenya and Europe. Eventually, that developed 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 as Quaxcl Technical Consultancy Services. We are endeavoured to excel high level of consistent technical, quality and regulatory services, teamed with collaborative effort by GXP experts and Engineers. The team members and associates are highly skilled, recognised in the Industry and backed with long standing practical experience.
. Coaching and training in GXP on Aseptic process, Engineering clean room, Biologics, Medical devices.
. Gap analysis, Due-diligence audit, and Business & Quality risk management as per ICH, ISO and WHO.
. Investigation, CAPA and response of deficiency (483, audit finding, etc) to the Regulatory bodies.
. Qualification and Validation of Facility, Utilities, Equipment – risk based approach ASTM 2500E guideline.
. Deployment and Upgradation of QMS, Cleaning validation, Process validation, Deactivation validation.
. Deployment of integrated vendor management system and Test laboratory quality management system.
. Analytical method validation, transfer, development of product specification, OOT & OOS, investigation, SAL in Microbiology.
. Strategic remediation support towards the warning letter, import ban by the Regulatory bodies.
. Recruitment of Technical staff, competency building. Implementing appraisal system & Quality indices.
. All time readiness audit preparation for WHO, MHRA, EMEA, INVIMA, ANVIZA, TGA, PICs, USFDA, GCC, ISO 13485 (CE), ISO 17025 (NABL) and ISO 9001 (2015).
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