Helping companies around the world navigate the regulatory maze

Regulatory / CMC Services

Our talented team of experienced consultants have the technical and regulatory experience to address your Chemistry, Manufacturing & Controls (CMC) projects and expedite your company’s regulatory and quality programs.

The Mapi regulatory CMC team works closely with our clients to provide CMC regulatory assessments and to ensure compliance with current global regulatory expectations. We provide CMC leadership for projects from product development through commercialization to lifecycle management of mature products for small molecules and biologics.

Our capabilities include a wide range of CMC regulatory services:

  • Drug development plans to meet regulatory, technical, & quality requirements at each phase of the product life cycle
  • Regulatory document content, consistency, and gap remediation
  • Global or regionally-targeted dossiers
  • Compliance with country-specific regulatory requirements
  • Address potential CMC concerns at pre-submission meetings
  • Negotiate with global agencies to address regulator concerns and facilitate CMC approvals
  • Regulatory support of commercial product initiatives
  • Minimize regulatory impact of post-approval changes

Review and/or preparation of CMC regulatory documents:

  • Module 1 - Quality related documentation
  • Module 3
  • Module 2 - Quality Overall Summary
  • Drug Master Files
  • Pre-meeting packages and responses to regulatory questions
  • Post approval submissions (variations/supplements)
  • Due diligence reports/gap analyses

Other CMC Regulatory Services include:

  • US and Canadian Agent services for foreign companies
  • Regulatory training
  • Legal support: Expert Witness - opinions/affidavits

Let our dedicated team help solve your CMC regulatory challenges.

Request a consultation with an Strategic Regulatory Services expert