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CMC

CMC

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Pacific Link Consulting has years of experience managing all stages of CMC (Chemical, Manufacturing and Controls) to ensure consistent drug development from preclincial through approval. PLC recognizes that streamlining CMC can improve the bottom line while maintaining an excellent level of control. A good CMC team can help ensure that your product is consistently effective, safe and high quality for consumers.

Keeping in mind that budget, time and quality are essential factors in any drug development, PLC will help develop the process based on client guidelines and risk tolerance. Our goal is to help our client maintain consistent product manufacturing throughout the entire process.

Our Chemical, Manufacturing and Controls team can provide:

  • Strategy
  • Fully comprehensive project plan
  • Pre-IND Chemistry Manufacturing and Controls development and implementation
  • CMC documentation package (IND, NDA, ANDA)
  • Ensure medical product is high quality
  • Ensure product is safe for use in individual
  • Drug/excipient/packaging compatibility
  • Early stage stability studies
  • Clinical manufacturing, Scale-up
  • Develop RA dossiers
  • Regulatory submissions
  • Document changes
  • Technical development
  • Quality Assurance
  • Ensure consistency throughout development
  • Determine requirement from regional regulators including Japan
  • Analytical methods validation
  • Manage CMO’s
  • New Molecular Entity Approval activities and requirements
  • Post Approval support
  • Assistance for companies who received 483’s and/or warning letters from the FDA to resolve CMC deficiencies

Please contact us at your earliest convenience to learn more about our CMC offerings.

 

 

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