In the current competitive landscape of Life Sciences, it is required to reduce the time-to-market for a quick product launch to take advantage of early success. For the same, manufacturers should ensure that all Regulatory aspects are adhered within the submission deadlines for successful approvals. If any observation is found by respective Health Authority in this entire process, it may lead to amendments and extension of timelines. How would you avoid these errors to maximize productivity?
The only way out is to continuously track applicable laws, regulations and supervisory guidance of targeted regions. Not only should the companies search for updates, but they should also deep dive to get a better hold of applicable intricacies and data glitches. They should gain a grip over technical aspects of the requirements and practical challenges in implementation as well. In a typical drug/device manufacturing company, as the emphasis would be more on the quality, safety and efficacy of the product being manufactured, decoding the laws and their applicability to the products for better marketability will be time-consuming and expensive for manufacturers. In such scenarios, they might have to invest on special resources – a team of Regulatory Affairs - who are technically well-versed and are knowledgeable on global Regulatory landscape.
As a strategic front, RA provides technical advice and assistance at the highest level, right from the conception, Regulatory data requirements, dossier compilation, submissions and all the way to successful market authorizations. Further, as the product progresses to the post-authorization stage, it caters to a multitude of product compliance needs such as lifecycle management inclusive of Regulatory gap analysis, health authority (HA) query management, and renewals. Overall, Regulatory Affairs, as a lifeline to life sciences caters to:
- Collect, collate and evaluate the scientific data gathered as part of R & D
- Advise on legal and scientific restraints and requirements
- Guide on international legislations, guidelines and customer practices
- Formulate the Regulatory strategy for submissions basing on the region-wise specifications
- Prepare and review SOPs related to RA
- Ensure the organization’s products comply with current regulations
- Coordinate, prepare and review all appropriate documents for timely submissions
- Keep up-to-date with the organization’s product range
- Review, gap analysis and change control of all relevant documents
To ensure a ‘right-first-time’ approach for a product’s successful go-to-market, it is required for manufacturers not only to evaluate a drug’s safety and efficacy but also track and understand the applicable laws and regulations for successful compliance. Have you evaluated your drug product/device against global regulations? Do it right away. Consult an RA professional. Be informed. Be compliant.