Avighnakalp Solutions (OPC) Pvt. Ltd. Dahisar, Mumbai, Maharashtra

Global Regulatory requirements are very dynamic and becoming stringent with respect to the development, manufacturing, and distribution of biopharmaceutical products. Given the dynamic nature of regulations, medicinal products’ manufacturers are facing challenges in decoding and understanding the updated Regulatory compliance requirements, choosing the right Regulatory submission roadmap, and developing an appropriate Regulatory strategy to enter into the global markets.

All packaging and Regulatory artwork labeling components (artwork copy, design elements) must comply with the regional/local market regulations and should carry all safety-related information as per the guidelines. The packaging and artwork labeling components shall be shared with the Artwork studio for artwork creation and should be validated by Regulatory artwork labeling professionals for packaging artwork design production. Without an expert review, the label or artwork or packaging might be non-compliant.

One of the most common challenges faced by the biopharmaceutical industry is the optimal investment of time and money, and effective Regulatory compliance initiatives to fulfil organizational business goals. Expert Regulatory consulting support and well-defined Regulatory strategies become essential factors in dealing with challenges in the product commercialization aspects and throughout the drug development process as well. 

Companies looking for quality artwork and labeling require artwork quality check and labeling quality check to ensure perfection, not just in terms of product technicalities, but also in terms of communicating the product usability to the end-user. Even a simple typo on the final artwork or artwork defects could cost an organization millions of dollars. There are several reasons why companies are unable to address this issue of artwork defects.    Some of them include: Lack of proficient artwork proofreading/QC professionals, with Regulatory artwork background Absence of electronic proofreading tools from the process Limited knowledge of Regulatory requirements

To enhance productivity and to optimise the operational cost, medicinal product manufacturers propose certain changes to the registered content of the medicinal product applications/dossiers. Any change to the registered content of medicinal products should be submitted to the respective Health Authority (HA) in the appropriate submission procedure with supporting data prior to its implementation. Based on the impact of the change, the requirement of prior approval would be determined referring to the CMC post-approval Regulatory affairs submissions (post-approval supplements/amendments/CMC variations) guidelines of the respective HAs. In this phase, the importance of the Regulatory strategy for post-approval Regulatory affairs changes submission is significant.

Medical Writing is a vital segment of clinical research. It plays a critical role in the development and submission of clinical research documents and defines the success or failure of new medicinal products/devices. As Regulatory authorities expect precise and timely submissions of documents/dossier, any delay in this stage leads directly to a delay in realizing profits both in terms of achieving patient benefit and ROI.

Marketing Collateral and promotional material, such as Visual Aids and Leave Behind Literature (LBLs) have been used by pharmaceutical firms for a long time. But with the advent of digital media and Pharma 4.0, we have seen a rise in the combination of physical and digital communication and digital promotion by pharmaceutical firms. DTC (Direct-to-consumer) Pharmaceutical advertising has also seen a large growth, especially in the U.S., where even prescription drug advertising is regulated but not barred.   The primary objective of any promotional material guided towards the public, or a part of it, is to communicate the benefits as well as the shortcomings (if any) of the medicinal product effectively and clearly. Advertising in the pharma industry should be done without obfuscating Regulatory constraints and following the pharmaceutical advertising regulations as mandated by the Regulatory authorities.

A Marketing Authorization Holder (MAH) is responsible for keeping the registered dossier up to date as per country-specific requirements for a products’ lifecycle management. Based on the concerned Health Authority requirements, the MAH should file an Annual Report (AR) or a Renewal Request on a periodical basis. For  annual reports or renewals, Health Authorities worldwide have a different set of requirements for filing the submissions. In such scenarios, to get the approval/acceptance at the earliest, a Regulatory submission strategy plays a significant role. Hence, manufacturers may wish to consider a specialized Regulatory consulting for CMC Lifecycle Management of the Regulatory Submissions for already approved products.

Avighnakalp Solutions (OPC) Pvt Ltd is a fully integrated transnational company. The company is focused on improving quality of patients’ lives by identifying and developing formulations that address unmet medical needs, Nutraceutical products and  personal care solutions.

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Adding to these global and regional procedural complexities, a handful of end-to-end Regulatory service providers make the situation even more critical for manufacturers seeking in-time global expansion in a cost-effective way. For example, if a US-based drug manufacturer is interested in marketing their product in the Middle East, they may require a service provider who has complete knowledge of the Middle East Pharma Regulatory market space along with some knowledge of a customizable suite of Regulatory services spanning across strategy to submissions, rather than a regular service provider who has expertise in only a single Regulatory function, and might incur huge costs for the drug manufacturer.

With the rise in demand for globalization and market expansions, Pharmaceutical manufacturers, of late, are forced to carry out all these activities at various locations, if not being assisted by globally distributed partners/vendors. Hence, the challenge persists in gaining comprehensive visibility into end-to-end processes which otherwise may lead to operational delays and affect the product’s time to market.

Regulatory assessment/Gap analysis of the supporting documents/data is critical for the registration of medicinal products. Though most of the Health Authorities (HAs) accept applications/dossiers in the CTD format, the level of content to be provided in the CTD section vary from each other. Thus, a thorough gap analysis/technical assessment of the documents/data enables the manufacturers to identify and mitigate the gaps before Regulatory submission. It will avoid Regulatory rejections of the submissions and minimize any major/critical queries to fasten the approvals.

Graphics are an essential aspect of visual communication and contribute to building brand value in the consumer’s mind. It is important to ensure that the graphic designs i.e.: packaging artwork designs comply with various Regulatory guidelines, especially for the most regulated industries like Pharma, Biotech, Cosmetics, Nutraceuticals, and Medical Devices. While doing so, without a state-of-the-art artwork studio, managing various design-oriented operational complexities like organizing multiple design tools, lack of proper version controls, untraceable working files, limited knowledge on Regulatory mechanisms, and demanding packaging and print supplier requirements affect an organization’s product launch timelines and costs.

Lifecycle management of Packaging Artwork and managing a Global Artwork Management System is getting complex day by day. Either through manual coordination or through Artwork PLM tool integration, intricacies in activities remain the same. Eventually, it is the responsibility of the artwork lifecycle management manager (Artwork Lifecycle management Coordination manager) to ensure that the designs are done on time for a smooth product launch. This requires a lot of coordination among various departments and functionalities. With businesses expanding across the globe, interacting with various stakeholders pose a great challenge for organizations.