CatalystBio
Lifecycle advisory firm providing end-to-end consulting and fractional leadership to biotech and life-science companies, supporting regulatory strategy, CMC and manufacturing scale-up, preclinical and clinical development, quality systems, program management, and diligence/fundraising activities.
Industries
Nr. of Employees
small (1-50)
Services
Advisory support for regulatory strategy, preparation of submission documents, and facilitation of regulatory interactions.
Definition of phase-appropriate CMC strategies, analytical method validation, manufacturing batch record drafting, and CQA/CPP assessments.
Design and implementation of quality systems, inspection readiness assessments, and remediation planning for regulatory observations.
Design and assembly of preclinical and toxicology data packages to support IND filings and first-in-human study design.
Trial design with registrational endpoints in mind, adaptive design implementation, and operational support for enrollment and study management.
Cross-functional program planning, timeline and budget management, contract oversight, and scientific communications support.
Advisory support for regulatory strategy, preparation of submission documents, and facilitation of regulatory interactions.
Definition of phase-appropriate CMC strategies, analytical method validation, manufacturing batch record drafting, and CQA/CPP assessments.
Design and implementation of quality systems, inspection readiness assessments, and remediation planning for regulatory observations.
Design and assembly of preclinical and toxicology data packages to support IND filings and first-in-human study design.
Trial design with registrational endpoints in mind, adaptive design implementation, and operational support for enrollment and study management.
Cross-functional program planning, timeline and budget management, contract oversight, and scientific communications support.
Expertise Areas
- Clinical trial management
- CMC and manufacturing strategy
- Quality systems and regulatory compliance
- Preclinical and toxicology study design
Key Technologies
- Mass spectrometry
- Analytical method validation
- CMC process scale-up
- Regulatory submission and Pre-IND engagement
News & Updates
Discussion on transitioning from executive operating roles into consulting and different consulting models.
Guidance on preparations to get value from a Type B Pre-IND meeting with the FDA, with key considerations before submission.
Announcement noting support provided to a client on a BLA submission to the U.S. FDA for a multicellular autologous therapy targeting diabetic foot ulcers.
Discussion on transitioning from executive operating roles into consulting and different consulting models.
Guidance on preparations to get value from a Type B Pre-IND meeting with the FDA, with key considerations before submission.
Announcement noting support provided to a client on a BLA submission to the U.S. FDA for a multicellular autologous therapy targeting diabetic foot ulcers.