Labelling workstream planning
An agreed view of the content, contributors and regulatory dependencies.
Product information & packaging
Labelling, artwork & patient information
Bring regulatory knowledge and practical coordination to product information, artwork design and maintenance, translation and serialisation support.
Keep product information connected to the regulatory programme.
We provide regulatory labelling and patient information support, with artwork design, artwork maintenance, translation and serialisation support delivered through selected partners. We coordinate the agreed activities as part of your RegConsult engagement.
When we can help
- A submission needs coordinated product information and labelling support.
- A launch or product change requires artwork design, updates or maintenance.
- Multiple contributors need a clear review and approval process.
- You need to scope patient information leaflet testing or related support.
- You need translation or serialisation support coordinated with the wider programme.
What the support can include
The deliverables are agreed around your requirement. A typical scope may include:
Regulatory content coordination
Support to prepare and coordinate the relevant product information and labelling.
Artwork design and maintenance
Artwork design, updates and maintenance through our selected partner, coordinated with the regulatory content and review activities.
Patient information support
Scoping and coordination of relevant patient information leaflet activities and testing.
Translation support
Translation support through selected partners, coordinated around the agreed product information, markets and timetable.
Serialisation support
Specialist serialisation support through selected partners as part of the agreed launch or lifecycle activities.
How we work with you
We confirm the product, markets, documents and current stage of the programme, then agree the activities and specialist input. RegConsult coordinates the relevant partner support and aligns responsibilities, reviews and handovers with your submission, launch or lifecycle plan.
Common questions
Can you support labelling alongside a submission?
Yes. Labelling can be scoped as part of submission support or as a separate workstream.
Can we involve our own artwork team?
Yes. We can agree how regulatory input, design work and reviews will be coordinated with your existing team.
Can you help with patient information leaflet testing?
We can discuss the testing requirement and the relevant specialist support as part of the agreed scope.
Let’s move your programme forward.
Start with your regulatory question. We’ll discuss the relevant expertise and a practical scope.