At Rubicon, we support a wide range of clients with the publishing and submission of variation packages for medicinal products, including well-known names from the high-street and brands who are just getting started. But what exactly is publishing, and why do companies choose to outsource it?
What is Publishing in Medicinal Product Variations?
Publishing is a crucial step in the process of filing variations for medicinal products. Variations refer to any change made to the approved content of a marketing authorisation (MA) dossier, and they’re an essential part of lifecycle management.
There are different types of variations, Type IA, IAIN, IB, and Type II, as well as extension applications, and all come with their own requirements. Whether it’s a simple administrative update or a more complex change, getting the submission right is vital.
That’s where publishing comes in. Once the variation documents are prepared, they must be formatted, compiled, and validated using specialised publishing software before they can be submitted to regulatory authorities.
Why Work with Us?
We support clients across the full variation process, from preparation and planning, to publishing and submission. Our regulatory publishing experts have experience in:
- All variation types
- Grouping, supergrouping, and worksharing procedures
- Ensuring high-quality, error-free submissions that meet regulatory requirements
Errors in publishing can delay validation and ultimately impact assessment timelines. Our job is to make sure that doesn’t happen.
Cost-Effective and Flexible
Many companies approach us specifically for publishing support, often because:
- We offer competitive rates compared to maintaining in-house capability
- Publishing software is expensive and not all organisations invest in it
- Expertise is hard to find, especially for standalone publishing tasks
Some clients opt to use our publishing service independently. They send us their finalised variation package; we publish it and send back a validated, submission-ready sequence. Simple, efficient, and reliable.
Need Help With Publishing?
Whether you’re looking for full lifecycle management support or a trusted partner to take care of your publishing, we’re here to help. Our team ensures your submission is complete, compliant, and ready to go, giving you peace of mind and saving you time. Contact us today!
