Specialized CMC Consulting for Biotech Success
BDBio, Inc. provides timely Biologics CMC consulting expertise tailored to your project’s unique needs, streamlining your development in a competitive industry.
CMC Guidance at all Stages of Biotech Growth
BDBio meets you where you are in the development lifecycle to ensure compliance and quality for each stage of drug development.
From pre-clinical to nearing BLA approval, BDBio has experienced support ready to work in lockstep with your internal experts.
Experience Expert Guidance with Tangible Results
Our CMC consulting talent stands ready to keep you on the path to approval.
Precision CMC Strategy
Receive nuanced Chemistry, Manufacturing, and Controls support that streamlines development and bolsters regulatory approval odds.
Industry-Forged Expertise
Benefit from seasoned professionals dedicated to advancing your biotech projects efficiently and effectively.
Tailored Regulatory Support
Navigate complex compliance landscapes with guidance designed to fit your unique product and company needs.
Expert CMC Guidance for Biotech Innovators
We deliver precise and timely advice and resources to Chemistry, Manufacturing, and Controls teams, tailored to accelerate your success.
Specialized CMC Strategy
Traditional Biologics or Biosimilars, BDBio brings expertise to streamline your product development and regulatory compliance.
Timely Regulatory Resources
Ensure your submissions meet industry standards with efficient and expert consultation; or let our team seamlessly integrate with your authoring efforts.
Tailored Technical Solutions
Customized guidance on Tech Transfer and Validation designed to address your unique challenges and accelerate your pipeline.
Benjamin Drucker
Founder and Principal Consultant
- Regulatory strategy
- Manufacturing and Tech Transfer
- Quality and Validation strategy
- Quality and Technical Risk Management
- Technical writing
Team members sensitive to their online presence are available in:
- Clinical Regulatory Strategy Development
- Assay Development and Validation
- Technical Writing and Application Preparation
- Tech Transfer and Validation
- SOP and Quality System Documentation development
