REMS is a recent and emerging regulatory requirement for all pharmaceutical companies, whereby the FDA expects these companies to monitor, submit plans, and proactively manage any and all safety risks in the sphere of their...
Read MoreIn the pharmaceutical industry, many companies often find it difficult to find a quality system model they can rely upon, as well as meet all of the required FDA initiatives. Because of these tight FDA restrictions, such as the...
Read MoreBy government mandate, the FDA is required to conduct regular cGMP inspections every year, at different manufacturing establishments that have association with FDA regulated companies. Because pharmaceutical production and...
Read MoreSuccessfully managing a cGMP inspection begins first with developing a clear-cut company plan, which will define the roles and responsibilities of everyone that will be involved in the inspection. Because the FDA can arrive at...
Read MoreUntil recently, standard treatment methods for serious bone loss due to bone fractures and bone disorders, have been limited at best. Standard treatments for serious bone fractures would encompass basically two treatment...
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Smart Pharmaceutical Consulting has made a major contribution to our manufacturing strategy and how we plan to operate our plant in the future.