Driving Innovation, Ensuring Compliance, Delivering Excellence

At StrataBio Consulting LLC, we specialized in strategic consulting for drug developers and services providers, focusing on optimizing operational effciencies and designing analytical pipelines to meet regulatory standards.

Effective analytical quality control (QC) is vital for the success of any drug pipeline, especially as cell and gene therapies (CGT) grow in complexity. StrataBio Consulting helps clients select and optimize robust testing methods tailored to each stage of development. For service providers, we guide the design of offerings and equipment to meet CGT manufacturing needs.

Critical quality attributes (CQAs), critical material attributes (CMAs), and critical process parameters (CPPs) are key to establishing a strong quality by design (QbD) program. StrataBio Consulting assists clients in identifying product CQAs and selecting the most suitable compendial and non-compendial assays for product characterization, release, and stability studies. Our team also evaluates outsourcing vs. in-house options and helps select the right service provider.

Whether transitioning from R&D to GMP, introducing a new assay in the laboratory, or transferring processes between teams, StrataBio Consulting LLC assists customers with protocol design, process oversight, data evaluation, and comprehensive reporting.

As the complexity of Advanced Therapies grows, comprehensive drug product characterization is becoming essential to meet evolving regulatory requirements. In this landscape, leveraging powerful "omics" tools, such as Next Generation Sequencing (NGS) and metabolomics, can significantly enhance product characterization and improve cost-efficiency for lot release testing. StrataBio Consulting LLC offers deep expertise in NGS platforms—including long reads, single-cell analysis, and spatial transcriptomics—providing our clients with a competitive edge to navigate these challenges successfully.

Interim executive  leadership

At StrataBio Consulting LLC, we excel at leading teams to achieve their goals while fostering a culture of excellence and strong work ethics that drive your company to the next level. Our senior team members are passionate about stepping into interim Vice President or C-suite roles, offering clients the benefit of seasoned scientific and operational leadership without the commitment and cost of a full-time executive.