Medical Information and Pharmacovigilance

Your Safety, Our Priority


 

Rocky Mountain’s highly tenured team of medical professionals have strong foundations in medical information, pharmacovigilance, and quality monitoring for continuous improvement. 


Our skilled US-based pharmacists are empathetic and responsive, and all interactions are non-scripted and conversational. We’re here to help you navigate and demystify the regulatory landscape. Whether you are bringing a new product to market or need custom solutions, we are here to help!


ISO 9001:2015 Certification was issued to Rocky Mountain Poison & Drug Safety through PRI Certification with the scope of RMDC (Rocky Mountain Drug Center) contact center, which includes Pharmaceutical Medical Information (MI), Product Complaints (PCs) and Adverse Event (AEs). Not only does this certification increase our Drug Center’s contact center confidence in providing services with efficiency that can be trusted, but our clients can also be assured that we have a transparent and robust quality management system to support their needs.
Access our certification here.

Streamlined Adverse Event and Product Complaint Intake

Robustly intaking Adverse Event/Product Complaint (AE/PC) data to reduce downstream effort for follow-up. Integrated transmission and reconciliation procedures support submission deadlines and regulatory audits with ease


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International Telephony

All-in-one telephony services including local and international routing, multilingual support, unified communications and strong quality assurance


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Pharmacovigilance

Facilitating timely and accurate reporting to regulatory authorities through the comprehensive assessments of product safety profiles


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Turnkey Medical Information Database

Offering highly configurable validated systems for Medical Information (MI), Adverse Event (AE) and Product Complaint (PC) intake alongside dedicated system administrators. This supports customizable solutions developed from industry standards and best practices


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Medical Information Insights

Customizing insights to provide real time visuals within an interactive dashboard. Identifying trends to support the evolution of customer needs and satisfaction


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System integrations

Streamlining integrations, most commonly content integration, and bi-directional CRM integration, with an emphasis on data integrity


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Our skilled US-based pharmacists are empathetic and responsive, and all interactions are non-scripted and conversational. We’re here to help you navigate and demystify the regulatory landscape. Whether you’re bringing a new product to market or need custom solutions, we’re here to help!

Postmarketing Surveillance

Surveillance Systems and Methods


Rocky Mountain’s postmarketing surveillance model is comprised of various data sources and methodological approaches, ensuring the most complete and representative information is provided. We optimize the therapeutic potential of pharmaceutical products by describing their real-world risks and benefits. "Rocky Mountain Poison & Drug Safety data are relied on by the US FDA and dozens of the top 100 Pharmaceutical Companies."

 

 

RADARS® System Surveillance and Expertise

Providing near-real-time product-specific and geographic-specific data with expert analysis and interpretation


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Mosaic Surveillance and Triangulation

Combining multiple data sources to strengthen findings, reduce the risk of misinterpretations and offer a comprehensive perspective on your study questions


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Observational Studies

Developing real-world studies designed to understand the effectiveness and safety of an approved drug


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National Poison Data System Studies

Interpreting and using the National Poison Data System (NPDS) database of America's Poison Centers


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Literature Surveillance

Monitoring scientific literature to identify relevant and current information related to pharmaceutical products on an ongoing basis


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Benchmarking and Safety

Comparing structured data to evaluate product outcomes  


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Rocky Mountain Poison and Drug Safety’s postmarketing surveillance model consists of multiple data sources and methodologies to ensure we provide the most complete and representative information. We optimize the therapeutic potential of pharmaceutical products by describing their real-world risks and benefits.

Scientific Communication

Optimize Scientific Communication and Credibility


Rocky Mountain Poison & Drug Safety helps you enhance scientific credibility, support effective communication and prepare materials both in the pre-marketing and post-approval stages. Maximize the impact of your research by using our strong information management capabilities.

Publication Strategies

Designing studies, analyzing data and developing manuscripts to ensure information is effectively communicated and disseminated. Analyzing and creating scientific messages to publish important results


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Medical Writing

Experts in generating materials, including adverse event reports, patient education materials, medication guides, signal detection and evaluation reports, which are accurate and easily understood by your target audience


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Scientific Annual Meeting

Striving to connect industry, academia, and regulatory experts to discuss the latest real-world evidence in prescription drugs and treatments.


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Regulatory Services

Bridging Science, Compliance and Safety


Rocky Mountain Poison & Drug Safety offers a variety of regulatory services, during product development, as well as in peri- and postmarketing phases. During product development we can help you navigate the complex regulatory landscape, ensure compliance and facilitate a smooth regulatory approval process.

Peri- and postmarketing, we help you maintain regulatory compliance, support risk management efforts and ultimately prioritize patient safety in the real-world use of pharmaceutical drugs and products. We bridge the gap between scientific knowledge, regulatory compliance and consumer safety, ultimately benefiting both the industry and consumers.

Regulatory Reporting and Consulting  

Providing guidance on regulatory requirements, preparing regulatory submissions and ensuring compliance with relevant regulations and guidelines


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FDA Guidance

Expediting reviews and providing resources to ensure compliance and facilitate regulatory approval


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Periodic Regulatory Reporting

Generating regulatory data, analysis and reports


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Risk Evaluation and Mitigation Strategy (REMS) Development and Fulfillment

Identifying, assessing and implementing measures to minimize product risks


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Abuse Potential Assessment

Developing epidemiological studies, pharmacovigilance and surveillance systems to provide insights about abuse potential.


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Risk Assessment

Providing refined tools to help you understand the overall safety profile of your product or drug


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Clinical Research

Our Expertise Streamlines Your Product's Journey

We evaluate drugs for poisoning treatment applications and orphan drug indications that involve multi-center operations, study management, data collection, data management, data analysis and reporting.

We have helped several drug companies to develop antidotes for poisonings in the US, including:

CroFab − North American crotaline snake envenomation

DigiFab − cardiac glycoside intoxications

Antizol − toxic alcohol (methanol & ethylene glycol) intoxications

Acetadote – acetaminophen intoxications

Radiogardase − thallium and radiocesium exposures

Cyanokit − cyanide exposures

Study Design

Addressing research questions with protocol development outcomes, design and methodology development to illustrate drug safety and efficacy


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Clinical Trials Project Management

Planning, resourcing and risk management for Phase II - IV clinical trials


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Patient Enrollment

Providing a data-driven, patient-centric approach to operations related to recruitment, screening, engagement and retention


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Clinical Data Management

Offering data collection and analysis, biostatistics support, CRF development and database management


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Clinical Site Investigator Network

Supplying an expanded network of patients through decades of site network experience


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Clinical Trials Monitoring

Reviewing data collection and records to ensure data integrity and regulatory compliance


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Industries

Your Industry, Our Expertise

Rocky Mountain Poison & Drug Safety offers a comprehensive set of services including medical information and pharmacovigilance, exposure management, scientific support, risk assessment and many more. 

We empower you to ensure the safety of your products in the real world.

Pharmaceuticals and Biotechnology

Providing regulatory support and fulfilling medical affairs needs for pre- and post-marketing phases

Medical Information and Pharmacovigilance

Postmarketing Surveillance

Regulatory Services

Psychedelics

Optimizing real-world data to support the safe use of psychedelic therapies

Postmarketing Surveillance

Regulatory Services

Consulting Services

Consumer and Household Products

 Championing consumer safety, product stewardship and regulatory compliance

Consumer Product and Chemical Services

Medical Information and Pharmacovigilance

Over-the-Counter Medications

Developing safety guidelines, undertaking surveillance and consulting

Postmarketing Surveillance Services

Consulting Services

Medical Devices

Offering 24/7/365 Pharmacist patient support center services

Medical Information and Pharmacovigilance

Postmarketing Surveillance

Regulatory Services

Antidotes and Antivenoms

Supporting clinical trials through postmarketing surveillance needs

Consulting Services

Clinical Research Services

 

Industries page main

RADARS® System

The RADARS® (Researched Abuse Diversion and Addiction-Related Surveillance) System is an innovative model for post-marketing and public health surveillance for abuse, misuse, and diversion of prescription drugs.

No single data source can provide complete and representative information about a group – multiple data sources strengthen the credibility of findings, reduce the risk of false interpretations, and provide a more complete and comprehensive perspective of the study question.

Learn more about the RADARS System

Rocky Mountain Poison and Drug Safety’s innovative model for postmarketing and public health surveillance for abuse, misuse and diversion of prescription drugs and other systems.

 

Exhibitions and Events

We continuously strive to stay active in emerging industries where there may be a need for our expertise.

 

We prioritize constant communication with our peers and customers through attendance at relevant exhibitions and events to ensure we have and share the most up-to-date information.

Psychedelic Science 2023

Denver, CO - June 19-23, 2023

National Association of County and City Health Officials (NACCHO) 360

Denver, CO – July 10-13, 2023

Toxicology Fellowship Program

Our experts are regularly producing publications, abstracts and posters sharing scientific expertise and insights for relevant conferences, exhibitions and journals. 

Annual Scientific Meeting

Image of 18th Annual Scientific Meeting

The RMPDS Annual Scientific Meeting strives to connect industry, academia, and regulatory experts to discuss the latest trends in prescription drug misuse and diversion.

This year we focused on: Emerging Surveillance Needs for Psychoactive Drugs.