More procedures and records are not necessarily consistent with a better compliance profile. Successful organizations use understanding of the Regulations and Standards as a means not only of being able to show compliance, but as a means of generating competitive advantage by incisively relating them to the attributes of their particular products.

Their products are safe and effective because they understand what needs to be controlled, and they have the procedures and practices to be able to assure third parties that they are being controlled.

The reasons for organisations being found non-compliant are varied, and the impact can be severe. Product quality may be compromised and financial harm to the business, through not meeting FDA or Notified Body expectations, can occur.

Our people have worked successfully with organizations both proactively, to prevent major compliance issues from arising, and reactively, where Regulatory authorities have addressed concerns in an audit report, or through the issue of FDA 483 items or a Warning Letter.