Regulatory Services
Streamline regulatory submissions and reduce the risk of rejections.
Analome has the expertise needed to navigate regulatory requirements and processes. We have successfully executed numerous regulatory science studies in accordance with global regulatory standards.
Proven success in our projects:
- Early product high throughput NGS-based transgenic and gene-editing event evaluation and selection
-
Production strain characterization by WGS – ID, virulence, & AMR
-
Early product bioinformatic testing for potential allergenicity and toxicology
- Early testing of soil organisms for field release permitting
- Full product molecular characterization for dossier submission