By Christina Bodurow, PH.D., Vice President, Global Regulatory Affairs, Data Sciences, Safety and Regulatory, IQVIA
A pharmaceutical treatment or device can be available to patients in the marketplace for decades. From first market approval through product innovations such as new indications, formulations, and second brands, every milestone in that lifecycle will be shaped by regulatory requirements. If a medicine’s sponsor wants to maximize the impact of the product on patients, providers and their own bottom line, they need to proactively make regulatory affairs part of their lifecycle planning strategy.
Regulators act as a checkpoint at every critical milestone on the product journey. When companies build regulatory strategy into the product’s lifecycle plan, they can optimize value, reduce risk, control costs and ensure compliance — from development through product management.
Such long-term planning is fairly common among the largest pharmaceutical companies, but small and emerging biopharma companies may lack the experience, expertise or resources to develop a comprehensive regulatory affairs strategy that can evolve with the product. This unplanned approach can create unexpected delays and potentially derail the long-term revenue potential of the product.
Such losses can be avoided when companies think through the product lifecycle during development to identify the regulatory expectations at every key milestone. This can help them proactively capture relevant safety and efficacy data to meet future global and local requirements.