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
Risk Evaluation and Mitigation Strategy (REMS) Development and Fulfillment
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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Why Rocky Mountain?
With over 65 years of industry experience, Rocky Mountain Poison & Drug Safety is the leader in providing specialized services spanning the lifecycle of a drug or consumer product to public health, government agencies, and the pharmaceutical and consumer products industries.We ensure the highest level of service to our clients by meeting their unique and complex needs.
