CMC Services

CMC Services2022-09-01T14:36:48-04:00

Drug development requires complicated manufacturing and process engineering. The Converge CMC Services team is comprised of chemical and process engineers, formulation experts, PhDs and highly skilled practitioners that have years of experience across company type, technology, dosage form, and therapeutic area.

We diagnose and assist our clients with their process development. This includes navigating rigorous quality assurance and quality control.

Process Engineering  |  Product Development  |  Analytical Methods  |  Formulation  |  Characterization  |  Stability

Our CMC Services experts know which strategies, systems and partners work best, as well as when to use them.

  • Are you a preclinical company looking for knowledgeable technical support as you write your IND and prepare to enter the clinic?
  • Are you an early clinical company already generating a lot of CMC data and looking to scale your manufacturing and supply chain to support later clinical trials?
  • Are you a late clinical company involved in Phase 2b trials and/or activities related to BLA, NDA, PAI, and PPQ that require tech transfer and support in planning to scale for commercial production?
  • Are you an established commercial company with a pipeline of clinical trial candidates and looking to extend the bandwidth of your CMC team or in need of specific subject matter expertise?

We can help you meet key business milestones and complete critical CMC initiatives.

I needed rapid and highly skilled assistance with complex CMC issues related to our NDA submission. Converge stepped in quickly with a no-nonsense approach and demonstrated the maturity and insight that one only sees with the most experienced industry veterans. Converge had access to a diverse and deep set of resources and fielded a team who delivered exactly what we needed. Our submission was a success and Converge helped the follow-on transition to our growing internal team. I would gladly go back to Converge for further CMC support as needs arise. The Converge team members developed a strong rapport with our full internal staff, not just me. They were well-respected by all. – CEO, Multinational Pharmaceutical Company

CMC Services

How do you ensure a reliable and scalable CMC?

  • Product, Process & Analytical Strategies
  • Buy vs. Build Decision-Making Support
  • Product Due Diligence & Technology Assessments – Compliance Audits
  • Portfolio Management – NPV/EVA Analysis
  • Quality System Design
  • Regulatory Support
  • Cell & Gene Therapy Expertise
  • Interim CMC Leadership
  • Process & Product Development
  • Analytical Development
  • Formulation, Characterization & Purification
  • Stability Testing
  • IND/BLA/NDA/SOP Technical Writing
  • Quality Systems (QA & QC)
  • CRO & QC Lab Selection
  • Contract & QC Lab Project Management
  • ARCC – Audit Ready Compliant Cloud (21CFRPart11)
  • eSubmission Systems (RegDocs365 eTMF)
  • Electronic Document Management Systems (EDMS)
  • Quality Management Systems (QMS)
  • Stability Testing (StabilityShire)
  • Process Data Management & Reporting/Dashboards
  • Lifecycle Operating Platform

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