Trusted CMC Advisors

Experts in biologics manufacturing, quality assurance, regulatory compliance and project management 

Your Partners for Success

At Chamow & Associates, we help biotech companies navigate the complex demands of product development. Our mission is to partner with clinical-stage biotechnology companies by providing integrated CMC services to bring new medicines to patients for testing.

Accomplished Industry Experts

Our skilled associates fully understand the technical and regulatory challenges of drug development. We have been providing strategic solutions that help companies overcome problems, meet deadlines, and deliver quality results since 2008. 

Our Services

Manufacturing Strategy & Operations

Provide strategic advice and guidance on the stages and costs of biopharmaceutical drug development.

Process Development & Optimization

Develop technical design for biotherapeutic production and optimize manufacturing processes.

Quality & Regulatory

Design management systems for filing documentation and regulatory approval.

Outsourcing Support

Identify, evaluate, select, and manage CDMOs (contract development and manufacturing organizations) for all CMC tasks.

GMP Facility Design

Assist with design validation efforts for manufacturing spaces.

Project Integration

Coordinate development activities with manufacturing processes.

Technical & GMP Training

Design and deliver on-site CMC, quality and regulatory compliance training.

What Our Clients Say

“ITB has a very pleasant and productive collaboration with Chamow & Associates. They [...] are essential when it comes to delivering our projects on time with the right quality. The consultants at Chamow & Associates perform above and beyond our expectations and we are very grateful for all their work.”
Peter Frank
Head of CMC, ITB-Med
“Chamow & Associates has made a significant impact on our therapeutic antibody program in taking responsibility for much of our early stage CMC development. Partnering with them has enabled us to remain focused to deploy our in-house resources in other areas until later in clinical development.”
Xiaodong Yang
President & CEO at Apexigen
“Their extensive knowledge and background in all aspects of CMC and hands-on approach were crucial for our first and timely IND submission. Steve Chamow has assembled a team of skilled experts on which we continue to rely on for advice in other areas such as Quality Assurance and Formulation."
Ute Schellenberger
SVP Protein Science, Teneobio

Companies We've Worked With

Our Latest Insights

Explore best practices and notable biopharmaceutical discoveries with our distinguished consultants.

Conferences

View our upcoming conference schedule and past presentations.

Publications

View textbooks, articles, and journal publications from our team.

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