NURTURES QUALITY CULTURE

Our Journey : : Consulting

collaborates

Qualxcl (Quality + Excellence) Technical Consultancy Services, a consultancy firm, formed under the Government of India company act in April 2018. The Bangalore based firm established by Goutam S Saha as Director.

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 Pharma, Bio-pharma and Medical Devices manufacturing while working in developed and emerging market. 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. Consequently, QUALXCL consultation firm was formed to deal with the technical deficiencies in the Pharmaceutical, Bio-pharmaceutical, Medical device Industries, and Testing laboratories and to support them comprehensively for short and long-term resolution.

The vision of the firm is to nurture quality culture laddering industries to the excellence of highest standard. We are endeavoured to excel high level of consistent quality services, teamed with collaborative effort 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 end-to-end and handholding services encompass extensive reference to the following standards and guidelines:

  • USFDA
  • MHRA, EMEA
  • WHO
  • PIC/S
  • ICH
  • TGA
  • ANVISA
  • Health Canada
  • Japan MHLW
  • DBT, RCGM, IBSE
  • ISO 13485/ CE, ISO 17025/ NABL, ISO 9001

Services We Provide

Qualxcl  Technical Consultancy Services

Our Capabilities

95%

Remediation of Warning & Import Alert

90%

Auditing, Gap Analysis, Investigation

90%

Quality System and GxP

80%

Training & Competency Building

90%

Supplier Evaluation

80%

Lean Laboratory & Process Throughput