Over the past 15 years the regulatory landscape has been evolving. Whereas previously regulatory compliance was mainly concerned with those stages of product lifecycle from scale-up and manufacture onwards, it has now been extended into the development phase of therapeutic and healthcare products. Concurrently, the complexity of inventions in biomedical and bio-materials fields has increased and the dividing line between medical devices and bio/pharmaceuticals has increasingly blurred. There is therefore an ever greater need to define regulatory and compliance pathways earlier in the product life cycle.
A recent study by the Ponemon Institute, “The True Cost of Compliance,” examined average compliance costs across 46 organisations with compliance budgets ranging from $446,000 to over $16 million. Averaged by organisational headcount, the per capita compliance cost came out as $222 per employee. By contrast, when non-compliance costs resulting from fines and penalties, policy enforcement, data protection, staff training, and system improvements were calculated across the same organisational headcount, the average cost was $820 per employee.
The increasing role of the SMEs in the discovery and development of new medicinal and healthcare products brings ever greater benefits to the patient. However, given the above landscape, this benefit can only be more fully and efficiently realised if SMEs recognise their product definition and compliance pathways at the earliest stage possible.
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