Expert Solutions for Biologics and Cell and Gene Therapies
Comprehensive expertise. Scientific Excellence. Unwavering integrity.
Expert Solutions for Biologics and Cell and Gene Therapies
Our Services
Program and Project Management
Strategic oversight, timeline management, and cross-functional coordination to keep your program and team on track.
Process Development and Manufacturing Oversight
Good Manufacturing Practices (GMP) process development and oversight to deliver consistent, high-quality therapeutic products.
Analytical Testing and Development Strategy
Assay development, product characterization, and release testing strategy for your product to enable robust regulatory filings and ongoing phase-appropriate support.
Preclinical Study Design and Data Analysis
Study design and data analysis of small and large animal data to enable appropriate reporting for regulatory filings.
Regulatory Strategy, Meeting, and Filing Support
Regulatory strategy development to ensure you can make the most of your meetings with regulatory bodies/health authorities toward filing of your regulatory application.
Clinical Trial Development and Oversight
Comprehensive development and oversight of clinical trials, including clinical start-up support, Institutional Review Board (IRB) filings, and data capture systems and data management oversight.