Supporting higher management to identify and delivering strategic and transformational Quality leadership drive for imparting Culture of Pharmaceutical Quality to provide successful international growth initiative in Pharmaceutical, Healthcare, Cosmetics.

Deliverables and achievements –

Provide effective compliance strategy and QIP (Quality Improvement Plan) for Quality Management of - Pharmaceutical/ Cosmetics (API), Biosimilars, Drug- Device combination products, Devices, Drug Substance, Drug Formulation, in Manufacturing and R&D operations. Services provided to various clientele- API, DF, Devices, IT.


Providing the desired support for steering organization through complex Quality & Regulatory challenges, remediation, transitions. Help identify and build an empowered Quality & Operations Team which is capable and empowered to deliver results within highly competitive products and regulatory environment. Effective implementation of Quality Systems including oversight of IT applications such as Tracwise®, Documentum®, LMS®.




  • Training - GxP compliance 

  • Audits - GxP

  • Pre-approval inspection (PAI) readiness

  • Operational readiness and sustainability programs (mentoring)

  • Formulation of CAP – corrective action plan

  • Assistance during regulatory inspections & post-inspection correspondence and meetings

  • Assistance to legal counsel in FDA enforcement matters

  • Due diligence of product and facility acquisitions



  • New Project Management

  • Quality & Compliance Strategy

  • QMS Initiation, Implementation, Review

  • Instill the Culture of Quality

  • Quality Management

  • Regulatory submission and site readiness

  • Resource Management for SOC (state of control)

  • Remediation Program

  • GxP Compliance Strategies


Udaykumar K. Rakibe, Ph.D.

Udaykumar is a quality professional with a dynamic career. Steering organizations through complex Quality & Regulatory challenges, transitions, building an empowered and talented workforce in the cross-cultural environment within highly competitive products and regulatory environment. 


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