Rondaxe

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Guiding you on the drug development path to success

 
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CMC Consulting Overview

Rondaxe CMC consulting group is focused on providing drug development and manufacturing strategies to the pharmaceutical industry, concentrating on providing services to emerging and specialty pharma companies. Rondaxe employs a diverse group of former directors, and senior directors from the pharmaceutical industry with expertise with chemical, fermentation, drug product and analytical development, supply chain strategy, manufacturing operations, quality control, quality assurance and regulatory affairs.

CMC Consulting

  • CMC Consulting
  • Chemical Development

    Chemical Development

    • Synthetic Route Strategy Development
    • Synthetic Route Selection
    • Regulatory Starting Material Definition
    • IPC & PAT Method Development

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  • Fermentation & Biocatalysis Development

    Fermentation & Biocatalysis Development

    • Strain Selection
    • Feed and Media Optimization
    • Protein Fermentation & Purification
    • Biocatalysis Strategy Development

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  • Analytical

    Analytical

    • Analytical Strategy Development
    • Analytical Testing/Validation

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  • Regulatory

    Regulatory

    • Regulatory Compliance Gap Analysis
      of product development plans and
      Submissions
    • Regulatory Evaluation and Strategy
    • Practice in FDA review meetings
    • Prepare regulatory fillings

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  • Quality

    Quality

    • cGMP Auditing
    • Stability Assessment/Program
      Design/Implementation
    • Vendor Audits
    • Pre-Approval Inspection Preparation
    • cGMP Remediation

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  • Supply Chain & Manufacturing Strategy

    Supply Chain & Manufacturing Strategy

    • Technology Transfer Planning and
      Management
    • Vendor Selection
    • Vendor Audits
    • Manufacturing Strategy
    • Manufacturing Process Development
      and Validation
    • Process Assessment and Optimization
    • Manufacturing Scale-Up
    • Technology Transfer

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  • Cost of Goods Analysis

    Cost of Goods Analysis

    • API manufacturing cost estimates
    • Model manufacturing processes
    • Detailed cost analysis
    • Analysis of technical and
      cost challenges of synthetic route
    • Understand labor/facility costs and
      raw material cost contribution
    • Direct your drug development efforts
      to drive down cost

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  • Drug Product Development

    Drug Product Development

    • Formulation Development
    • Excipient/Ingredient Selection
    • Analytical Methods Development
    • Report Documentation

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  • Process Research & Development

    Process Research & Development

    • Cost effective bench scale scale laboratory
      research of process ideas
    • Explore alternative synthetic routes
    • Asses economic and regulatory impact of
      findings
    • Reduce costs and time to filing
    • Improve product quality and process robustness

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