Success Stories

Commissioning, Qualification, and Validation (CQV) for Facility, Manufacturing, and Laboratory Equipment and Systems
Pharmaceutical and Medical Devices KVALITO’s highly experienced CQV Subject Matter Experts perform Commissioning, Qualification and Validation activities for systems, equipment and laboratories in the life science sectors using industry best practices and sound...
Global Project Management in Regulatory Affairs
KVALITO supports Life Science companies in leading global cross-functional mergers and acquisitions, GMP, Regulatory and Clinical programs and operations in various project stages, including Drug Discovery, Preclinical, Clinical, Manufacturing and Marketing.  ...
Automation of Software Development Life Cycle (SDLC)
Automation of Software Development Life Cycle (SDLC) FDA's Center for Devices and Radiological Health (CDRH) intends to publish a new guideline in the Fiscal Year 2021 (FY 2021) [R1]; "Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System...
Transformation- Cell & Gene Therapy Platform Operations & Compliance
Transformation- Cell & Gene Therapy Platform Operations & Compliance Design, development and implementation of complex orchestration platforms enabling (personalized) Cell & Gene Therapies (CGT) and maintenance of compliance through operational services,...

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