SafetyCall® provides 24/7 adverse event management services which include the rendering of professional medical or veterinary clinical advice to manage and document adverse effects in animals or humans after exposure to any product in the marketplace.
One of the keys to Product Safety is making sure that all products are used correctly. Through its 24/7 Call Center, SafetyCall provides direct to consumer advice regarding safe and intended use of a wide variety of products. SafetyCall professionals can alleviate consumer fear and misunderstanding when communicating safe product use practices.
Whether your product is pre-market or post market, your adverse event data and data analysis supports good product stewardship and is extremely valuable. This data can help confirm a predicted risk profile as well as yield important information regarding unintended and unexpected effects or use patterns. Informed and expert analysis of this data is essential for accurate interpretation. This eliminates the risk of data being misinterpreted or taken out of context.
SafetyCall provides turnkey regulatory reporting for all relevant State and Federal agencies, including:
When the joint Industry/EPA committee on 6(a)(2) reporting met to design a national voluntary incident reporting format SafetyCall experts helped to coordinate the process and authored the guidance document.
With SafetyCall’s expertise you will always be on top of any EPA or FDA reporting requirements. We are your most trusted resource in regulatory compliance and reporting.
SafetyCall Drug Information Services provide comprehensive information to health care professionals, patients, and client representatives. This information helps them achieve optimum utilization of drugs and medical devices with safe and effective outcomes.
The consulting practice of SafetyCall International, PLLC augments existing company resources to help satisfy new and evolving requirements. SafetyCall Consulting Group is uniquely qualified to provide integrated consulting services in many areas of science and regulatory affairs. These services directly apply to important statutory requirements (such as FIFRA, TSCA, Proposition 65) and related activities. The SafetyCall Consulting Group has demonstrated leadership in safety assessment for product development efforts as well as for post-marketing safety surveillance for consumer products, PMRA and Dietary Supplements.