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CMC (Chemistry Manufacturing and Controls) is at the core of most of MakroCare’s Regulatory activities. Over the years, our CMC breadth and depth was developed to support several needs of clients.

MakroCare has institutionalized several flexible delivery models for providing CMC Consulting services that includes:

  • BulletCMC regulatory strategy, critical review and assessment, related to the content of the DS (Synthetic or semi-synthetic small molecule, natural product, peptide) and DP (tablet, capsule, patch, cream, wafer, solution, injectable) Quality Modules (Module 2: QOS and Module 3: Quality) of the Common Technical Document (CTD) for regulatory submission
  • Bullet Interpretation and application of CMC Regulatory Regulation & Guidance
  • Bullet CMC Regulatory Gap Analysis for Identification, Assessment and Provision of CMC Regulatory Mitigation Strategies for Remediation
  • Bullet Authoring of Annual Reports, Dossier Amendments and Supplements
  • Bullet Preparation, Publishing and submission of global applications
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