Delivering tailored solutions to our clients to help them navigate regulatory complexity and speed time to marketing authorization
Our expertise
Service Lines
Chemistry, Manufacturing & Controls (CMC)
Lead technical, quality and regulatory expertise in process development & manufacturing, analytics & formulation development and quality & compliance.
Support for the submission lifecycle of drug, biologic, device or combination products from pre-IND through licensure to project timelines, monitoring of project resources, etc.
Support for drugs and biologic products; early-stage development planning assistance, nonclinical program review and strategic support for FDA submissions.
We offer clients an array of tools and services that enhance collaboration, streamline the application drafting process, and reduce regulatory review times.
