Success with Lifestyle, Genetic, and Rare Metabolic Therapies
We strive to advance your novel metabolic therapies from Phase I-III clinical development to market with confidence.
Our experienced teams are poised to plan and implement these efforts quickly, providing:
- Development of regulatory strategy, expedited pathways, and regulatory agency interactions
- Clinical program planning, inclusive of statistical planning and analysis
- Agile patient recruitment strategies to support virtual trial and hybrid approaches
- Rapid deployment of clinical trial databases and data analysis and migration into CDISC formats
- Virtual and remote clinical and medical site monitoring
- Writing of clinical trial, safety, and regulatory documents
- Preparation and defense of Marketing Applications – NDAs, BLAs, NDSs, MAAs, jNDAs, etc.
- Post-Marketing Pharmacovigilance and Safety Monitoring to ensure patient safety beyond regulatory approval
Proven Expertise for Success
are for Rare/Ultra-Rare Disorders
are Genetic Disorders