CatalystBio
CatalystBio is a global advisory firm focused on the life sciences sector, providing integrated end-to-end consulting services to biotechnology companies. The firm specializes in advancing product development from initial discovery through regulatory approval, offering strategic direction and operational execution to help organizations achieve critical milestones efficiently. Services span regulatory affairs, CMC, quality, preclinical and clinical development, diligence, fundraising, and company buildout.
Industries
N/A
Services
Advisory services including preparation and management of regulatory submissions, agency interactions, and alignment of product development with evolving global regulations.
Development of scalable manufacturing processes, drafting of batch records, process characterization, and analytical validation.
Development and implementation of quality systems tailored to various stages of product development, including inspection readiness and remediation.
Design of pre-IND packages, study report drafting, and management of preclinical/toxicology vendors.
Design and execution of clinical studies with registrational endpoints, adaptive design implementation, and streamlining of clinical operations.
Cross-functional planning, timeline and budget development, contract management, and facilitation of scientific presentations.
Advisory services including preparation and management of regulatory submissions, agency interactions, and alignment of product development with evolving global regulations.
Development of scalable manufacturing processes, drafting of batch records, process characterization, and analytical validation.
Development and implementation of quality systems tailored to various stages of product development, including inspection readiness and remediation.
Design of pre-IND packages, study report drafting, and management of preclinical/toxicology vendors.
Design and execution of clinical studies with registrational endpoints, adaptive design implementation, and streamlining of clinical operations.
Cross-functional planning, timeline and budget development, contract management, and facilitation of scientific presentations.
Expertise Areas
- Regulatory affairs
- CMC strategy
- Quality systems in biotech
- Preclinical development
Key Technologies
- Analytical method validation
- Adaptive clinical trial design
- Quality management systems
Key People
News & Updates
Contributed support for a successful BLA submission for an autologous cutaneous multicellular therapy.
Official launch of CatalystBio as a global life sciences advisory firm.
White paper discussing timing, preparation, and best practices for Pre-IND meetings and their impact on regulatory and clinical planning.
Guidance for maximizing the value of FDA Type B Pre-IND meetings, highlighting key pre-meeting considerations.
Article discussing career transitions in the life sciences sector, focusing on consulting models and executive expertise.
Michael Boyne and Greta Wodarcyk participated in a panel discussing the importance of clinical planning in company strategy.
Contributed support for a successful BLA submission for an autologous cutaneous multicellular therapy.
Official launch of CatalystBio as a global life sciences advisory firm.
White paper discussing timing, preparation, and best practices for Pre-IND meetings and their impact on regulatory and clinical planning.
Guidance for maximizing the value of FDA Type B Pre-IND meetings, highlighting key pre-meeting considerations.
Article discussing career transitions in the life sciences sector, focusing on consulting models and executive expertise.
Michael Boyne and Greta Wodarcyk participated in a panel discussing the importance of clinical planning in company strategy.