© 2017 by Pharma Mantra Experts

SERVICES

Role we play -

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 industry.

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 are given below:

      Quality

  • Training - GxP compliance, Investigation CAPA, Root Cause,  

  • Gap Assessment Audits - GxP

  • Pre-approval inspection (PAI) readiness

  • Strategy and advise - to formulate and implement a sustainable Quality System

  • Operational readiness and sustainability programs (mentoring)

  • Formulation of CAP – corrective action plan

  • Assist in Regulatory inspections & Response writing, post - inspection

  • Assist in Legal & FDA enforcement matters

  • Due diligence of product and facility acquisitions

         Advisory

  • New Project Management – Facility, Product, Contract Test Lab

  • Activities in - R & D, Manufacturing, Quality & Compliance Strategy

  • Help in the QMS Initiation, Implementation, Review

  • Instil the Culture of Quality

         Consultancy

  • Quality Management – R & D, Manufacturing Operations (API, DF, Devices)

  • Regulatory submission and site readiness

  • Resource Management for SOC (state of control)

  • Remediation Program

  • GxP Compliance Strategies

This site was designed with the
.com
website builder. Create your website today.
Start Now