Life sciences industries are stepping ahead with new initiatives every day to align with the growing Regulatory restrictions put forth by the health authorities. But as the supervisory expectations of agencies are evolving at an increased pace, at times, organizations are finding it challenging to align with all of them on time. In this scenario, instead of implementing the updates whenever they are revealed, it is required to stay prepared well ahead. However, to do so, some of the challenges may deter the efforts of compliance. Basing on the growing compliance requirements, major problems that life sciences organizations face in the current era could be:

Compliance Based on Ethics and Integrity: Industries must shift from simple rules-based compliance to ethics and integrity-based compliance and foster better accountability on their part. This is possible by introducing a common code of conduct across the company and by training the employees to abide by it at all levels. Not only does this improve organizational efficiency but it also increases the chances of successful approvals and better branding of the company in the eyes of global Regulatory Agencies.

Cost-Optimization: Costs avoided are revenues earned for any organization especially who are into manufacturing of medicinal products/devices. All processes and operations established to ensure a product’s compliance are laden with costs. So, they must aim at cutting down costs without affecting productivity. To achieve this, companies must streamline the product development process while reducing risk. Companies must focus resources only where it reduces manual and time-consuming activities and must implement global standards.

Decentralized Regulatory Operations: Regulatory operations in many organizations are disparate, functioning within the limits of their departments. E.g., the label and artwork teams must work in coherence as their functions are interdependent and any change in one of the Regulatory aspects such as artwork modification might affect both of them. Similarly, other aspects of product submissions are interdependent like graphic designing, proofing and printing, and hence managing entire Regulatory process under one roof or centralizing the entire process can help reduce the cost of errors within organization.

Lack of Process Automation: Regulatory processes can be repetitive and time-consuming. Often, companies fail to meet deadlines due to the extensive tasks in preparing the submissions and applications. For e.g., if you wish to take an already approved product to another country, you might not require preparing the entire documentation again. But can avail the part of already approved dossier which can reduce the man efforts, time and costs. The time delays caused by repetitive tasks can be averted if manufacturers use automated tools such as publishing and submission software that simplify the Regulatory operations and save time which can be used in other core operations.

Go-to-market Time: Once the market approval for a product is obtained from a health authority, the patent expiry countdown begins. The expiration of license means the product is no longer unique as it was when it got approved and it is legally allowed for other competitors in the market to develop similar products. This trend is majorly known to affect the drug products, and developers only have a narrow window to earn back the capital investments. The onus lies on manufacturers to quicken the process of bringing the product to the market, reduce the time and bank on the drug’s acceptance by end-users.

While all the aforementioned are generally observed challenges for life sciences organizations, there might be many hidden which require an expert Regulatory partner’s assistance. With the right Regulatory and market strategy, better view on implementation of regulations and use of advanced tools, life sciences organizations can overcome the challenges. Be prepared. Be compliant. 


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