Being in compliance with your pharma client's regulatory guidelines is not only essential to the successful launch of a project, but is critical to maintaining a healthy client relationship. Failing to meet the client's regulatory requirements can result in the loss of time, money, and strained client relationships, not to mention putting the agency's integrity in question.
At the end of the day, the responsibility for a successful review of a pharma project's submission rests squarely on the agency’s shoulders. It is imperative that the agency not only knows the client's regulatory requirements inside and out, but has established a process to ensure efficient quality control of project submissions.
The planning of the project submission begins during the actual creative briefing. While the creative team is listening to the project objectives, and has begun brainstorming concepts, the project manager concurrently maps out the submission process and considers key obstacles that could derail a regulatory review. It all boils down to communication and research.
Ongoing communication is key
Constant and open communication within the agency is critical. Just as soon as a concept is approved and the content/design development begins, it's important to question any areas that could create potential roadblocks during the regulatory review to ensure that your project submission will be bulletproof. Does the client only accept primary references, or are secondary references allowed? Are the references up to date and legitimate? Perhaps the Mayo Clinic has put forth a new study and the claim you referenced is now outdated. Maybe you're submitting a new Web site. Are all of the links functioning properly to the correct destination pages? If pages are linked to third-party Web sites, do those Web sites fall within the guidelines?
Just as important as internal communications, is communication within the confines of the client's regulatory committee. It is important to establish and maintain a relationship with agency counterparts who will help shepherd the submission along. This communication should begin at the conception of the project and continue throughout its lifespan.
Briefing them on the project early on may help ward off problems later. Ask what types of reviews might take place. Will it be a formal meeting with the reviewers, or will they review your project independently, on their computers? What if the agency has developed a dynamic Web site that could be overwhelming for the reviewers? Perhaps a pre-review consultation will help to alleviate questions/concerns during the actual review. This will help determine the necessary level of detail that you will need to provide.
Research, research, research!
Researching what's going on in the world of pharmaceutical marketing outside of your client's business is imperative. Pay attention to industry Web sites to see if there are any new DDMAC guidelines that your client may not be aware of. Investigate whether there have been any recent FDA warning letters issued that could impact your project. The client looks to the agency to be the knowledge expert, and to own the submission process. Don't wait for them to update you. You should notify them.
The world of pharmaceutical marketing is ever-changing, and more stringent regulatory guidelines could have an impact on your project submissions. Having an established submission process in place and knowing the client's guidelines as well as (if not better than) they do will help ensure compliance.
At the end of the day, if a big idea cannot be fully executed, it is just that -- an idea. It all comes down to execution.