In the highly regulated and dynamic pharmaceutical industry, medicinal product-related promotions and advertisements aim to increase brand awareness, generate sales, or create brand loyalty.  A high amount of pharmaceutical budget (nearly 9.3 million U.S. dollars in 2022 as per Statistics (Marketing budgets of U.S. healthcare companies 2019-2022; Published by J. G. Navarro, Jul 28, 2023)) is spent on these promotions and advertisements. These promotional materials must pass through a rigorous review process which could be challenging at different times to meet regulatory constraints and business goals. These challenges can be overcome with defined strategies.

In this blog, we shall explore the complexities that pharmaceutical companies generally face during a medicinal product’s advertising and promotional review. By understanding the challenges and implementing effective strategies, companies can efficiently navigate the Regulatory landscape and achieve their marketing objectives.

Strategies to overcome review challenges.

1. Transition from one market to another

Launch of medicinal products worldwide can be a challenging task as pharma companies may sometimes lack region-wise promotional and non-promotional guidelines awareness. Due to this they can easily run into conflicting requirements and may deviate from required promotional guidelines.

How can we help?

At Freyr, we provide support to customers in product launches and help them with their objectives in terms of worldwide material review and validation for medicinal products. Our medical, legal, and regulatory (MLR) review services provide relevant, up-to-date advice and make sure that you remain competitive in this highly complex environment. With our AD-Promo Guide, we provide country-wise guidelines. Our medical and scientific communication (MSC) CoE provides region-specific promotional and non-promotional material creation, designing from training to full-blown project management

2. Process risk and compliance issues-

Based on the complexity of promotional and non-promotional assets, the reviewing process may take place anywhere between 30 days to 6 months. This causes a bottleneck effect on vital digital assets being stuck for weeks between stakeholders. These bottlenecks cause a delay in the launch of the product and create frustration between stakeholders. Another risk is companies may try to deviate from their usual review procedures to speed the process with seemingly simple, nontechnical reviews. This may cause non-compliance issues and rejection by health care authorities (HA).

How can we help?

To overcome these challenges, we prioritize complex stakeholders by clearly identifying their roles and responsibilities. We support them with various risk stratification strategies co-created by medical and compliance professionals from Freyr. Among it involves, reviewing, substantiation, fact-checking, content management, and stakeholder meetings which reduces the overall turnaround time for each asset to 50% by improving its accuracy and efficiency. Regulatory compliance is always our focus and helps companies with the smooth submission of promotional materials to HA. We also take care of a fast-track review process that helps companies to stay aligned with stringent timelines.

An efficient escalation process is created to categorize and manage risk. It is important to assign in project owner who can identify project risks and mitigate them for the proper launch of the content.

3. Brand management

MLR review processes are labor-intensive and exceptionally detailed. Companies may struggle with huge amounts of promotional and non-promotional materials for brand management and its submission worldwide.

How can we help?

Freyr MLR reviews experts to check each document for its compliance and compatibility with existing content management systems. We use trier-based strategies for reviewing various assets for faster review. A tier-based robust metrics tell us how long it takes to review and approve marketing materials, and which brand materials should be reviewed as a matter of priority. We use a “document proofreading tool” that can review pieces of content before and after review to confirm all changes and reduce the need for multiple itineraries.

To overcome your Promotional review challenges, Contact us!

To overcome your Promotional review challenges, Contact us!

4. Considerations for Emerging Digital Platforms and future-ready materials

Adapting to the requirements of each digital platform striking a fair balance in limited character counts and addressing every user-generated content could be challenging.

How can we help?

Companies are moving towards omnichannel content, which is more user-friendly, allowing them to start on one channel and conclude on another based on their preferences and terms. Due to these, numerous changes have been made to the review process. We support that each omnichannel digital asset is adhered to new and updated regulatory requirements of HA and it undergoes a smooth submission process worldwide.

Successfully navigating the challenges of advertising and promotional review in pharmaceutical drug products requires a proactive and collaborative approach. Engaging MLR experts, streamlining internal processes with effective strategies, monitoring campaigns, staying up to date, and addressing compliance issues with regulations will help companies achieve their marketing objectives while maintaining Regulatory compliance. Embracing these strategies will enable companies to promote their products effectively and responsibly, ultimately benefiting healthcare professionals and patients.

If you are looking for support in advertising and promotional material review, consult a proven Regulatory expert. Freyr has assisted global pharmaceutical companies in achieving compliant and accurate promotional strategies. Contact us to learn more about our expertise!


Dr. Sonalli Ganguly


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