As all medical device manufacturers know, life sciences firms are bound by GxP rules and recommendations. Firms that want to create and maintain marketable product lines must be willing to subject themselves to intense regulatory scrutiny. They also have to comply with a range of rules pertaining [...] Read More
Companies which manufacture and distribute pharmaceuticals in domestic or international markets face more scrutiny than ever from regulating authorities, including the FDA and European Regulatory Authorities. Much of this scrutiny revolves around drug safety, also known as pharmacovigilance.
Appropriate and effective risk management and supply chain safety and security protocols are vital for FDA and EU compliance. There [...] Read More
The manufacture and sale of medical devices, be they intravenous catheters or operating tables, is a highly complex undertaking requiring a deft balancing of FDA regulatory concerns with ambitious output [...] Read More