ApproachCompliance

Regulatory compliance not only protects patients from errors or malpractice, it also protects the industry from lower quality operators with less than honourable intention. In a global economy the manufacture of pharmaceuticals could be anywhere in the world and, indeed, benefits of scale of production may drive such centralisation. Standards, however, need to be applied either at a global level or, at least, regionally. GxP standards are accepted by the entire developed world and, even where they are not obligatory, reputable companies still apply these standards. SOLABS is helping its customers recognize regulatory compliance as a strategic advantage, in all GxP areas i.e., GLP-GCP-GMP. 

During the drug development process the standards applied to each element change. Good Laboratory Practice (GLP) applied during the preclinical and Phase I/II stages is replaced by Good Manufacturing Practice (GMP) from Phase III onwards. Similarly, the practices applied in live animal research (LAR) are exchanged for Good Clinical Practice (GCP) as soon as human clinical trials begin. The overlapping interfaces are where there is a great deal of information exchange in order to maximise upon learnings of earlier phases. This is a particular pain point where SOLABS can help. By understanding the appropriate regulations and providing systems and expertise at these interfaces, SOLABS can ensure that best practices are implemented and compliance achieved. Knowledge transferral is facilitated because no paper-based documents are lost in the process.