Regulatory Insight for Qualifying Your Innovative Drug Development Technologies
Expert insights for every step of qualifying a novel drug development technology.
Are you considering submitting your technology to the FDA’s ISTAND program? We offer competitive, flat pricing packages for the design, preparation, and submission of your ISTAND Letter of Intent (LOI). Contact us here for a free consultation.
Guidance for Integrating NAMs into Your Regulatory Submissions
With the recent publication of the FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies, NAMs will become an integral component of IND, NDA, and BLA submissions.
Partner with experience. InnovApproach can help you plan and seamlessly integrate NAMs into your existing pipeline.
Quality Consulting for In Vitro Lab Service Tools and Cell Culture Manufacturing
The OECD Guidelines on Good In Vitro Method Practices are becoming the quality standard for in vitro testing. The FDA and EMA have taken note.
From ISO to GLP to GIVIMP, InnovApproach can build the Quality Management System you need to get to the next level. We have the experience to support planning, process scaling, and quality management for cutting-edge, cell-based goods and services.
Business Development Support for Cutting-Edge Drug Development Tools
Build a strategy to connect your technology to the clients who need it.
Designing and qualifying a novel tool is half the battle. Let InnovApproach help you create a comprehensive business development plan so potential clients can understand the value your technology brings to their program.