Life sciences companies increasingly understand the power and value of partnering. But what does that mean when it comes to managing the publishing process?
By Anja Westphal, Regulatory Engagement Management, CSC
In her recent blog, Someone to Watch Over You: The Benefits of a Submission Manager, my colleague Usha Sharp described the role of a submission manager and the benefit of having a single point of contact in the submission process. I’d like to take this a step further by describing the advantages of working with a submission manager in your own region.
Having a single point of contact in your time zone makes both logistical and strategic sense since any concerns, questions or immediate changes can be handled during your working day. You also have someone you can communicate with as and when required in a way that best suits your needs or working style, for example via email or a phone call.
Instant and Broad Support
Having a regional submission manager who works alongside a global team of submission management experts gives you further leverage when managing the life cycle of your product. For example, when you receive urgent requests from the health authorities, you can quickly alert your local submission manager, who can get the wheels in motion before handing over the files to an experienced global team to manage any responses and updates.
Once you’ve provided your files and tracking sheets – the benefits of which we discussed in a previous blog, The Benefits of Tracking Sheets for Regulatory Submission – your submission manager can begin the review process and pose any initial questions he or she might have. The submission manager will then get in touch with the publishing team to start working on your submission. Typically, small submissions, changes and a quality review are handled by a team that same day, ensuring you have your submission available by the next day. More extensive submission needs are generally handled by global teams to ensure around-the-clock support.
For example, a Europe-based life sciences company has a large and critical submission to deal with. After discussing the issue with their EU submission manager, the submission may be handed over to a publishing team in India to deal with tactical tasks. That team may then work with a U.S. submission manager to handle complex or urgent questions and issues if the EU submission manager has left work for the day. Any activities that need to be finalized could then be handed over to a publishing team in China, for example, before being returned to the EU submission manager at the start of their working day. Issues that arose during the night would then be communicated to you, allowing resolutions to be quickly incorporated. Finally, the team in India can once again pick up the submission and may be able to provide the sequence for review that same day.
The two most significant advantages for you are:
- Your submission manager takes on the huge coordination effort, meaning all you need to do is communicate with a single point of contact and focus on your core activities
- Having a partner with around-the-clock support allows the submission to be managed in 24 hours as opposed to the 3 days it would typically take if your partner lacked the global reach
Life sciences business process services combines these valuable capabilities – a local submission manager with a strong global team – to minimize complexities for you and maximize delivery.
Learn more about the BPS journey and working with a partner by downloading our white paper, Regulatory Business Process Services: A Strategic Enabler.