We assist Pharma and REMS administrators in all phases of drug development, pharmacovigilance and REMS activities, from new product development, through annual FDA reporting, and architecture modernization.
Advancing REMS Product Innovation
We apply deep and up-to-date, cross-domain clinical, technical and regulatory knowledge to assist Pharma and REMS administrator vendors in designing innovative REMS solutions that meet customer and industry needs.
EHR Integration
Design EHR+REMS Workflows
Bidirectional Transfer of REMS Requirements into EHRs
FHIR Interfaces
Automate Clinical Information Transfer
Pharmacy Management Systems
Integration with Independent, Mail, & Retail Pharmacies
EHR, Pharmacy, & Patient Apps
App Stores e.g. Epic App Orchard
What We Do
REMS Product Development & Strategy
- REMS Program Design
- SDO / Standards Development
- System Design & Product Integration
- Regulatory Strategy and Support
REMS Delivery and Support
- DLC and Program Consulting
- Data Integrity Compliance
- Reporting
- Regulatory Submissions
What We Know
REMS Guidance and Regulations
- REMS Program Requirements
- Drug Safety and Pharmacovigilance Principles
- Current FDA regulations and guidance regarding REMS, including Medication Guides, Shared REMS, Survey Methodologies, etc.
- SDLC Requirements
- 21 CFR Part 11 Requirements
Health IT Standards, Engineering and APIs
- Technology vendors and APIs/integrations (Epic App Orchard, SalesForce Health Cloud, others)
- NCPDP Standards
- FHIR Standards
- Managing API access according to security, privacy and other requirements
- Reliability and Scalability
- Interoperability
- Application of AI and other emerging technologies
