Ensure the safety of your pharmaceutical products with our regulatory services. We provide dedicated services and manage the regulation of health agencies such as the FDA (Food & Drug Administration) and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Our regulatory professionals are experts in clinical trials, compliance, manufacturing, patenting, compliance, sales & marketing, finance, IT, and scientific writing.
Our regulatory services include:
- Assisting in the development of procedures to ensure regulatory compliance
- Collecting data & preparing submissions to regulatory agencies
- Facilitating identification and resolution of regulatory & scientific issues with regulatory agencies
- Participating in the development of new products & services
- Remaining current with federal & international regulations and communicating that data within the organization, including designing training materials
- Participating in quality audits