THinc . . . a REGULATORY AFFAIRS DEPARTMENT
For clients who need regulatory affairs support, we can help you strategize, formulate, and develop solutions to regulatory issues and prepare and process submissions that are compliant with regulatory guidelines.
Chemistry, Manufacturing, and Controls (CMC)
Integration of regulatory CMC into a multifaceted drug-development program results in effective and efficient product development. THinc partners with clients to
- Develop and implement regulatory CMC strategies based on the development stage
- Identify potential CMC issues that could adversely impact the clinical program
- Critically review CMC documentation
- Prepare CMC regulatory submissions consistent with current guidelines and industry trends
