CMC (Chemistry, Manufacturing and Control) is often the critical factor in whether or not a company succeeds. Careful consideration is paramount regarding the technical, regulatory and compliance aspects when developing a therapy.

In order to ensure your program progresses and avoids set backs or insurmountable challenges, proactive specialized guidance and support is paramount during drug substance and drug product development and combination device development, where applicable. ABC is here to help.

Technical and Regulatory Strategy

• US, European and UK Health Authority guidance in accordance with real-time requirements - partner to assess, advise and employ phase-appropriate regulatory and technical CMC strategy.

  • Targeted and lean “smart strategy is always employed taking into consideration runway, resources and stage of development.

CMC Regulatory Partnering

• US/EU/UK Agency Interactions - Strategy & Execution

• M3 and IMPD preparation

• Partner on response to Agency requests for information

• Problem solving/change control

CMC Technical Advisory

• Advise on GMP requirements

• Advise on characterization/CQA requirements including:

  • Potency assay strategy

  • Release and stability testing, specifications

• Mfg technology transfer and comparability

• Partner with client regarding CMO RFPs, CMO negotiations/Steering Committee Mtgs

• Due Diligence