Galen – the secure choice for your product
As part of the Almac Group, Galen has access to a highly experienced team of dedicated professionals based at our global headquarters in Craigavon, Northern Ireland, who provide key services across the functions of Regulatory Affairs, Pharmacovigilance and Medical Affairs to support the commercialisation of your products.
Regulatory Affairs
Our Regulatory Affairs experts work across all areas of product development, licensing and lifecycle maintenance.
We’re alert and responsive to changes in the regulatory landscape and their potential impact on new and existing products, making Galen a proactive and secure partner.
- Product development and licensing activities
- Development of regulatory strategies.
- Contribution to product development programmes.
- Authoring, compilation, and submission of applications for market authorisation (eCTD operational).
- Advice and guidance on licensing requirements across multiple territories.
- Management of regulatory agency interactions pre- and post-authorisation.
- Key experience in Nordic compliance procedures.
Lifecycle maintenance
Our lifecycle maintenance services are streamlined to maintain compliance, while minimising the impact on the supply chain and on your product in the marketplace.
Pharmacovigilance
Our experienced team of professionals is responsible for ensuring that Good Pharmacovigilance Practice is maintained for all of Galen’s products.
Our Pharmacovigilance System is well-established, and the team has substantial experience in all the key elements of post-marketing pharmacovigilance. We use an industry-standard pharmacovigilance database and receive and process adverse event reports for many of Galen’s partners.
We adopt robust reconciliation activities for partner oversight and are available to discuss any support requirements you may have.
Medical Affairs
Our Medical Information team consists of life-sciences and pharmacy graduates, with 24/7 medical support; we provide a full medical information service for all Galen’s products in the Nordics.
A prompt and accurate medical information service is vital to support the commercialisation of any product.
We also assist with the review of your promotional materials, in line with Nordic legislative and Industry Code of Practice requirements.