Maintenance of Marketing Authorisations
Getting your product onto the market is a major regulatory hurdle, but the challenges don’t stop there. All MAs need to be varied at some stage: whether this is due to changes in the manufacturing process, or new business partnerships that impact on the supply chain, the regulators need to be informed of any amendments to the dossier originally supplied. Perhaps your marketing ambitions have changed, and you wish to bring your products into additional territories or use them in new target species. Conversely, internal strategy, mergers or planned divestments may require some authorised products to be sold to another company, suspended or even removed from the market.
Post-Marketing Procedures for Veterinary Medicinal Products
The outsourcing of post-marketing activities, for authorised products, to Cyton can help you achieve your objectives more efficiently, and can maximise product sales by freeing up your own staff from the need to process routine work - allowing them to work on priority projects. Our dedicated Regulatory Procedures Team acts as a stable workforce extension to the resources of your in-house departments. We offer flexible, tailored solutions for every one of our clients, so we can give you as little or as much support as you need.
Our regulatory and technical experts will ensure that your product authorisations are current, valid and safe. We make it our business to know all we need to know about your products in order to protect against any threat to their licensing status and avoid any potential for non-compliance.
Among the EU regulatory procedures with which we can assist you are:
- Line extensions – to add new target species, strengths or pharmaceutical forms
- Repeat-Use Mutual Recognition Procedures
- Variations (Type 1A, Type 1B or Type 2; single, grouped or worksharing)
- Marketing Authorisation renewals
- MA Holder transfers
- Pharmacovigilance and labelling maintenance
- Legal status (distribution category) re-classifications
- Portfolio expansion
Over Two Decades of Professional Experience in Veterinary Regulatory Affairs
With over twenty years’ experience of working side by side with marketing authorisation holders, local affiliates, manufacturers and distributors, we understand the importance of effective communication and quality management when implementing regulatory updates. You can rely on Cyton to manage the downstream effects of regulatory activities, ensuring that SPC updates are followed-through to packaging updates and potential stock-out situations are avoided.