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Service

Rapid Pharma Development-RPD offers Service and Consultancy in
 

Chemistry, Manufacturing, Controls

  • Sourcing of starting materials, intermediates and API

  • Chemical and biochemical process development

  • Analytical methods development and validation

  • Regulatory specification development

  • Stability study design

  • Physicochemical characterization and structure elucidation

  • Regulatory Support such as GMP-Audits, IND and NDA submissions

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API Development

  • Cost of Goods calculation

  • Identificaton of cost drivers and optimization parameters

  • Selection of appropriate CRO and CMO

  • Management of contractors, including analytical, bioanalytical, formulation, process development, manufacturing, labeling, packaging and quality control

  • Guidance on and execution of technology transfer and process validation

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Formulation Development

  • Preformulation study design

  • Formulation optimization

  • Manufacturing process development and optimization

  • Development report preparation

  • Process validation design and report preparation

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Quality Management Support

  • Preparation and Execution for Audits and Inspections

  • Quality Systems, Handbooks, SOP, Guidelines

  • Validation of Processes

  • Calibration of Instruments

  • Qualification of Equipment

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