Biotechnology

Regulatory expectations are fast-moving in the world of biotechnology — however, clinical evidence, controlled process steps and inspection readiness are expected to remain as disciplined as ever.

We provide regulatory interface assistance (e.g., biologic products, cell & gene therapies, etc.) for both interfaces and advanced therapy platforms; we assist in the creation of companion diagnostics regulatory strategy; we assist in development of clinical stage biotech programs and at drug-device combination products.

Our goal is to allow biotech teams to translate complicated aspects of their product biology into a simple and clear regulatory framework: Development Stage Strategy; Agency Interaction Planning; Quality System Maturity; Clinical Trial Readiness; IND/BLA Support; Diagnostic Alignment; Supplier Oversight; Lifecycle Compliance. As such, our services are ideal for those who require executive level regulatory thinking without the size of overhead associated with larger consulting firms.