SafetyCall health care professionals serve nine different product markets. This diversity allows us an excellent opportunity for benchmarking of incidents across similar and dissimilar product lines. SafetyCall experts use their proprietary systems and processes to monitor adverse incident trends related to each product. Our wealth of data from around the world allows us to determine if there is a product issue that puts a company or consumer at risk and advise clients on appropriate action to deal with virtually any product.
Ag-Chem Products and Pesticides
Companies that manufacture and/or sell Agricultural Chemical products and pesticides have incident reporting requirements mandated by the Environmental Protection Agency (EPA) in the USA and the Pesticide Management Regulatory Agency (PMRA) in Canada. If you have pesticides registered with the EPA or the PMRA, SafetyCall can assist you in meeting your regulatory obligations, and assist your customers immediately with any product-related health or safety concern.
Animal Health and Veterinary Products
This broad industry can include regulatory obligations mandated by both the EPA and the FDA, depending on the products, ingredients and intended uses. Whether your animal products are pharmaceuticals that fall under FDA guidelines or external products that do not, our staff of experts are here to help you comply with regulations.
Are you compliant with the FDA regulatory guidelines as they relate to Dietary Supplements? Guidelines for these were enacted under the Dietary Supplement and Nonprescription Drug Consumer Protections Act, which was passed into law in 2007. All alleged adverse events involving dietary supplements must be documented and retained for a minimum of six years, regardless of severity. Any allegation of a serious adverse event must be submitted to the FDA within 15 days. With over a decade of experience in this, SafetyCall makes compliance simple and easy.
Consumer Goods cover a wide range of products used by individuals and families, including cleaning, automotive, personal care and food items. Many of these products may be subject to the rules of the Toxic Substance Control Act (TSCA) Sections 8(c) and 8(e). Under TSCA, companies are required by the EPA to record, retain and in some cases report “allegations of significant adverse reactions.” SafetyCall specialists are experts in generating such reports, while simultaneously helping to manage the event if needed.
Industrial Chemicals are used at the professional level to make other products, such as plastics, paint, and explosives. Companies are required by the EPA to know if their products fall under the Toxic Substance Control Act (TSCA), and to record, retain and, in some cases, report “allegations of significant adverse reactions” to products in that category. This includes any substance/mixture the companies produce, import, process or distribute, and that is not subject to mandatory surveillance compelled by other regulations. SafetyCall will ensure that the compliance of your company is beyond reproach, and is always here to assist your customers and their employees with product-related safety concerns.
Institutional products are primarily used in the janitorial or cleaning industry. Many of the products used in this industry are subject to the rules of the Toxic Substance Control Act (TSCA) Sections 8(c) and 8(e). Under TSCA, the EPA requires companies to record, retain, and sometimes report “allegations of significant adverse reactions” to such products. SafetyCall will document and manage any adverse event or safety concern regarding your institutional products, and you can rest assured that your compliance meets any standard.
There are many classes of medical devices, each with differing levels of complexity and regulatory mandates enforced by the FDA. Medical device reports (MDRs) describing serious adverse events must be submitted to the FDA within 5 days or 30 days, depending on the nature of the report. SafetyCall makes sure your reports are accurate, thorough, and done on time.
Drugs: Nonprescription (OTC)
Do you know your adverse event reporting obligations for nonprescription over- the-counter (OTC) drugs? Manufacturers of nonprescription drugs in Canada and the US are respectively required to comply with the stipulations of the Canadian Food and Drug Act and the Dietary Supplement and Nonprescription Drug Consumer Protections Act, which passed into US law in 2006. These laws mandate that certain standards of adverse event reporting be met, and SafetyCall will ensure that your company meets those standards to the letter.
The safety of prescription drug products is monitored by regulatory agencies both pre- and post-market. US and Canadian pharmacovigilance practice guidelines describe the mandatory reporting requirements for serious adverse events reported domestically, internationally, and in the scientific literature global surveillance. Further, they provide the requirements for the preparation of periodic adverse drug experience reports containing a critical analysis of all adverse drug events occurring quarterly or annually, depending on the age of an approved drug. The software tools used by SafetyCall staff ensure that every required detail is captured and organized in a way that is usable to your company as you work to improve the safety of your products, and the regulatory bodies that oversee the safety of your products.