Intelligent marketing for your product

With demonstrable sales and marketing expertise, We have proved to be a commercially agile business partner – a must in the increasingly competitive arena of new product launches.

We are comprehensively equipped, through responsive and intelligent marketing, to successfully champion your product to launch and sustained growth.

Product differentiation 

Effective product differentiation is central to our sales and marketing activity, achievable through:

• a well-informed strategy
• a clearly defined value proposition for your product
• incisive and compelling marketing communications
• ongoing engagement with healthcare professionals, medicines management and relevant patient groups.

Flexibility 

Our team stays alert to fresh market insights and regulatory updates to anticipate, and respond to market dynamics and competitor activity.

• Proactive and reactive marketing maintains prescribing impetus.
• Market vigilance assures the continuity of relevant support for partner products.
• Key Account management – re-appraisal and adaptation, as appropriate.

We are positioned to distribute products across many global regions including the UK, Ireland, the Nordics, Europe and the USA. Our impressive reach proves an attractive proposition to potential partners.

Our extensive experience of managing supplier relationships, for our own and our partners’ products, ensures that stock supply will always fulfil product demand. We look after your products as we would our own, to ensure your product has the best chance of success.

• A strong relationship with all wholesalers guarantees your product is available in both high street and hospital pharmacies.
• Our storage and distribution facilities allow for shipping to wholesalers – and direct to hospitals.
• To facilitate distribution, products can be shipped to our distributors in various locations, with whom we have a longstanding and dependable partnership.
• We work with authorised distribution partners for product distribution throughout the many regions in which we operate.
• Our robust distribution and regulatory support is complemented by the expertise shared through our membership of the Almac Group.

We have the capacity and capability to make a compelling offer of integrated solutions for distribution, supply chain and logistics to potential partners – now and in the future.

Galen – the secure choice for your product    

As part of the Almac Group, We have access to a highly experienced team of dedicated professionals based at our global headquarters in 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 us 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 UK, Irish and other European agency national and pan-European procedures, and other global territories including the USA.

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 are responsible for ensuring that Good Pharmacovigilance Practice is maintained for all of our products. 

Our Pharmacovigilance System is well-established, and the team has substantial experience in all of the key elements of post-marketing pharmacovigilance. We use an industry-standard pharmacovigilance database, and receive and process adverse event reports for many of our partners. 

We adopt robust reconciliation activities for partner oversight and are available to discuss any particular 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 our products and our partners’ products.  We work across multiple territories, including the UK, Ireland, EU and USA.

A prompt and accurate medical information service is vital to support the commercialisation of any product. We are happy to develop bespoke services to meet individual partner requirements, including the development of responses to frequently asked questions, training and regular reporting for partner oversight.

We can also assist with the review of your promotional materials, in line with legislative and Industry Code of Practice requirements.  Our experts use industry-standard support mechanisms and our procedures are in-line with the requirements of the Association of the British Pharmaceutical Industry (ABPI), European Federation of Pharmaceutical Industries and Associations (EFPIA) and US Food and Drug Administration (FDA).

If you would like to find out more about our comprehensive regulatory affairs, pharmacovigilance and/or medical affairs support for our partners, please contact us. 

Solution-focused market access

We have amassed a raft of skills and competencies to take a product through the more challenging stages of market access. It isn’t a ‘one size fits all’ process, and our dedicated team tailors a strategy to suit the product, excelling in a solution-led approach.

Our strength lies in our rich experience in securing market access for products across a range of therapy areas.

For our partner products, we specialise in:

• Managing submissions to national healthcare appraisal and assessment bodies.
• Collaborating with national and local payers on pricing and reimbursement.
• Driving inclusion in:
  • national guidelines
  • hospital formulary listings and protocols/pathways
  • Area Prescribing Committees and primary care formularies.