CMC Regulatory & Drug Development Consulting

Expert Driven Drug Development

Chemistry, Manufacturing, and Controls

Chemistry, Manufacturing and Controls (CMC) information is required by Health Authorities to ensure product safety, manufacturability, efficacy, consistency and quality. The early implementation of a comprehensive CMC strategy will serve as a road map for your advance therapy development program, mitigating potential program delays, IND or BLA rejections, clinical study holds, and costly revisions to manufacturing processes and/or analytical testing methods.

Implementing a CMC Strategy

Landmark Bio provides comprehensive Regulatory and CMC consulting services aimed to (1) ensure the highest quality product and program, (2) reduce program timelines via a comprehensive risk assessment and mitigation plan, and (3) reduce program cost via program specific CMC road mapping.

  • Target product profiles (TPP)
  • Process and Product characterization
  • Phase appropriate quality control testing and specifications
  • Critical Process Parameter (CPP) and Critical Quality Attributes (CQA)
  • Interactions with Health Authorities
    • Preparation and planning for meetings with regulatory authorities.
    • Direct interaction and participation in meetings with regulatory authorities

Derisk and Accelerate your Advanced Therapy Program

Landmark Bio leverages wide-ranging CMC experience, and as your partner Landmark Bio will function as an extension of your team, making our extensive experience and knowledge directly available to you. Landmark’s leadership team has directly led and contributed to:

  • Over 150 drug development and technology transfer programs
  • The realization of 46 approved drug products
  • Over 45 BLA submissions
  • Over 64 process and method validations
Connect with a CMC & Regulatory Expert
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