Global CMC Regulatory Consulting Services

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

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

• CMC 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
• Interpretation and application of CMC Regulatory Regulation & Guidance for IND, CTA, IMPD, DMF, NDA, ANDA, MAA
• CMC Regulatory Gap Analysis for Identification, Assessment and Provision of CMC Regulatory Mitigation Strategies for Remediation
• Authoring of Annual Report, Drug Master Files, Dossier Amendments and Supplements
• Preparation, Publishing and submission of Electronic Common Technical Document (eCTD) applications
• Quality by design expertise