REMS Product Development and Regulatory Support
We assist pharma and REMS administrators in all phases of drug development, pharmacovigilance, and REMS activities, from new products through annual FDA reporting and architecture modernization.
Risk Evaluation and Mitigation
Strategy
(REMS)
A Drug Safety program required by the U.S. FDA regarding certain medications with serious safety concerns to help ensure that the benefits outweigh its risks.
REMS are designed to help support safe use of drugs with serious risks that may otherwise not be approved and available on the market.
When the FDA determines that a REMS is necessary, the manufacturer is responsible for the program. Some manufacturers hire experts to develop and implement the programs on their behalf. That's where we fit in.
Stakeholder Audit Services
Our team of experts regularly conduct high-stakes Technical Audits, Patient Safety and Process Audits, detailed Root Cause Analyses (RCA) and execute Corrective Action and Preventive Action (CAPA) plans to monitor and ensure compliance of all stakeholders. We apply safety-driven engineering principles to conduct comprehensive Risk Assessments that inform creation and execution of robust Audit Plans across all stakeholder groups. In doing so, we emphasize Continuous Quality Improvement activities and implementation of Best Practice Recommendations to affect permanent resolutions.
Specific to REMS audits, we are adept at these critical services:
- Patient Safety and Non-Compliance Risk Assessments
- Innovative audit methodologies to inform and establish detailed Audit Plans
- Stakeholder Surveys
- Suspected Non-Compliance Investigations
- RCA & CAPAs
- Compliance Monitoring
- Continuous Quality Improvements & Best Practice Recommendations
FDA Assessment Reports
Quandary Peak is specialized in high-stakes support and advisory roles on technical regulatory subjects.
Technical and scientific writing are at the core of our services. We author government‑sponsored and peer-reviewed scientific and technical publications. As a team we possess the required clinical knowledge and the necessary organizational capabilities to deliver high‑quality FDA REMS Assessment Reports. We compile a complete, accurate, and fully validated data set, including cross-references of the system vendor data to deliver an informative FDA Annual Assessment Report.
Advancing REMS Product Innovation
Our Health IT experts have deep domain expertise and experience in prescriber and pharmacy workflows, e‑prescribing technologies, and Health Information Exchange standards and technologies.
We apply modern, 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, and Retail Pharmacies
EHR, Pharmacy, & Patient Apps
App
Stores
(e.g. Epic App Orchard)
What We Know
REMS Guidance and Regulations
- Stakeholder workflows including but not limited to EHRs, Pharmacy, REMS administrators, and wholesalers
- 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 (e.g. Epic App Orchard, SalesForce Health Cloud)
- NCPDP and HL7 Standards
- FHIR Standards
- Managing API access according to security, privacy, and other requirements
- Reliability and Scalability
- Interoperability
- Application of AI and other emerging technologies
What We Do
Stakeholder Audit Services
- Patient Safety & Compliance Risk Assessments
- Audit Plans
- Stakeholder Audits: call centers, print/mail vendors, print fulfillment vendors, drug master file holders, pregnancy registry vendors, FDA report vendors, patient/prescriber survey vendors, documentation vendors and program oversight vendors
- Investigations & Reporting Activities
- Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) plans
- Proactive Risk Mitigation strategies, Best Practices & Recommendations
- Continuous Quality Improvement Processes and Procedures
- 21 CFR Part 11 compliance
FDA Assessment Reports
- PMO engagement across all Stakeholders and Sponsors to ensure on time delivery
- Vendor and stakeholder collaborations and continuous engagements to ensure access to accurate and up-to-date data
- Compile raw datasets into detailed tables and diagrams to present the data in clear, definitive and insightful manner
- Robust quality control process checks
REMS Product Development & Strategy
- REMS Program Design
- SDO / Standards Development
- System Design & Product Integration
- Product Management
- Regulatory Strategy and Support
REMS Delivery and Support
- DLC and Program Consulting
- Data Integrity Compliance
- Reporting
- Regulatory Submissions
Meet Our REMS Consulting and Drug Safety Team
Our consultants have experience with REMS product development and regulatory support.
Brad Ulrich has a diverse career as a computer scientist, software engineer, technology manager, and entrepreneur. His experience spans software design, programming, patent management, healthcare, mobile devices, startups, technology licensing, regulatory compliance, and risk management.
LitigationLitigationSenior Testifying Expert
Health ITFocus AreaSoftware & Standards
Due DiligenceArea of ExpertiseHealth IT & Standards
Dr. Ajit Dhavle is a healthcare technologist, clinician, entrepreneur, and a problem solver with 20 years of experience in digital health, quality, e-medications, Health IT standards, and patient safety. He oversees a team of health informatics experts to provide strategy, management, SDLC, compliance, and audit services to government and commercial entities.
Health ITFocus AreaHealth IT & Life Sciences
Alicia Morton Farlese is a retired Captain serving twenty-six years in the United States Navy Nurse Corps, and was a senior leader in national health IT policy at the US Dept. of Health and Human Services. Dr. Farlese assists clients in meeting Health IT regulations, including Information Blocking requirements of the Cures Act.
Health ITFocus AreaCompliance & Government Affairs