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CMC Writing

Developing Chemistry and Manufacturing Control (CMC) documentation for regulatory submission

Nextar provides quality Chemistry, Manufacturing, and Controls (CMC) services. Our quality assurance experts are an integral part of the team from the inception of your project. The CMC team provides thorough knowledge of the EU and US Regulatory Guidances, as well as experience from developing over 50 products. Hence, can summarizes and provide a comprehensive CMC report for regulatory submission.

Our CMC consulting services include identification of information appropriate for regulatory submission, including :

  • Gap analysis for the assessment of the level of implementation of requirements
  • conclusion of formulation development, analytical, stability and production data
  • Summary and conclusion of  toxicology, and clinical data
  • Revision of documents
  • Development, preparation, and review of CMC acquired data and its documentation