Services

Chamow & Associates offers services from experienced consultants with specialized knowledge and technical expertise in biopharmaceutical drug development. While the primary focus of our business is preclinical development through to IND, we partner with biotechnology companies across all phases of drug development, providing strategic advice and solutions to skilfully navigate both regulatory and technical processes.

 We help our clients to understand and manage risk, and in doing so, to manage time and costs and ensure our clients’ success. Our services include:

Consulting

Provide strategic advice and guidance on the stages and costs of biopharmaceutical drug development. Assist management in planning:

  • Budget and timeline estimates for preclinical development
  • Preclinical proof-of-concept studies
  • Process design and optimization
  • Assay development and qualification
  • Conduct due diligence on asset as potential acquisition
  • Formulation development and stability
  • Reference standard preparation
  • Production of toxicology and cGMP lots

Process Development / Optimization

Develop technical design for biotherapeutic production. Optimize manufacturing processes with respect to:

  • Cell line development
  • Upstream development
  • Downstream development
  • Formulation development
  • Product and process characterization

Outsourcing

Identify, evaluate, select and manage contract manufacturing organizations (CMO’s) for all CMC tasks. Provide assistance with:

  • Identify and recommend CMOs based on “fit” for project
  • Review and help to negotiate master services agreements
  • Cell line, process and assay development
  • Process and assay transfer
  • Clinical production
  • Clinical filling
  • Commercial manufacturing
  • Process validation
  • Facility design

Quality and Regulatory

Assist with quality and regulatory processes:

  • Design quality management system
  • Write SOP’s
  • Author CMC sections of pre-IND briefing documents, IND and IMPD filings and BLAs
  • Review and approve quality agreements
  • Approve quality documents of CMO’s
  • Perform vendor audits

Project Integration

  • Integrate development activities with manufacturing processes; partner with clients and CMO’s to form an integrated CMC team
  • Coordinate activities of integrated CMC team
  • Develop timelines and budgets for IND/BLA activities
  • Prepare pre-IND briefing package and CMC section of IND

Training

On-site CMC and regulatory compliance training. In-depth training that teaches clients to plan and execute product development and manufacturing strategies, and to integrate CMC activities with regulatory requirements to ensure quality and compliance throughout the product life cycle.

Please contact us to discuss how we can help you
Download our brochure
Steven M. Chamow, Ph.D., Principal Consultant |
San Mateo, CA
|
650-345-1878
| info@chamowassociates.com
© 2019 Chamow & Associates |