medical device documentation requirements
Industries We Serve:
Combination Products
Here’s How We Can Help
Whether you’re entering the market as a wearable delivery device or converting your vial into a pre-filled syringe, combination device documentation requirements are rigorous. We’re here to help tackle your:
- Essential performance requirements
- Human factors study documentation
- Product control strategies
- Design control matrices
- Device & design history files
Delivering Regulatory Services that Make a Real Difference.
Regulatory Writing
Consulting Services
Additional Services
GLOBAL Resources
IND vs. NDA: Understanding the Difference in FDA Submissions
For drug developers, FDA approval is a long and complex journey. Two of the most important milestones on this path are the Investigational New Drug (IND) application and the New Drug Application (NDA). While both are critical submissions, they serve very different purposes.
The FDA’s CMC Development and Readiness Pilot (CDRP) Program: What Sponsors Need to Know
In August 2023, the U.S. Food and Drug Administration (FDA) announced the launch of the Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program. This initiative is designed to help sponsors of certain accelerated development products better align their CMC strategies with the FDA early in the development process.
CMC Challenges in Cell & Gene Therapy: How to Avoid Regulatory Delays
In recent years, cell and gene therapies (CGTs) have transformed from scientific breakthroughs into commercial realities. These advanced modalities are redefining how we approach rare, genetic, and otherwise untreatable diseases—offering patients options that were once unimaginable. Yet, while the science is groundbreaking, the CMC (Chemistry, Manufacturing, and Controls) pathway remains one of the most significant obstacles to timely regulatory approval.