Regulatory Affairs, Pharmacovigilance & Medical Affairs
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 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 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 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.
We are positioned to distribute products across many global regions including the UK, Ireland, the Nordics and wider Europe. Our impressive reach proves an attractive proposition to potential partners.
Our extensive experience of managing supplier relationships, for its own and its partners’ products, ensures that supply of manufactured products is matched to in-market demand.
A strong relationship with all wholesalers guarantees your product is available in both community 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 reliable partnership.
We work with authorised distribution partners for product distribution throughout the many regions in which we operate.
Our robust distribution and regulatory support are 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.
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 leverage our deep understanding of the healthcare industry and our extensive experience in navigating the complexities of achieving commercial success within the pharmaceutical sector. Our expertise allows us to offer robust out-licensing opportunities that can drive growth and innovation for you.
By partnering with us, you can access commercially viable pharmaceutical products without the substantial investment typically required for research and development. This not only reduces your costs but also accelerates your time to market, allowing you to enter and compete more quickly.
The products we have available for out-licensing are designed to meet the highest standards of quality and innovation, ensuring that you can confidently bring new solutions to your customers. The collaborative nature of out-licensing helps mitigate risks, providing you with support through our proven processes in regulatory approval and commercialisation. This strategic approach fosters long-term growth and creates valuable partnerships, ultimately leading to our shared success.
By working with us, you benefit from our proven track record of successfully commercialising and managing pharmaceutical products worldwide. Together, we can achieve greater innovation, market expansion, and mutual success in the ever-evolving pharmaceutical landscape.
We are the ideal partner for you if...
You need to diversify your existing product portfolio with proven pharmaceutical products.
You aim to enter new markets or expand your presence in existing markets with proven products.
You are looking to accelerate the time it takes to bring new products to market.
You want to work with a team that has a proven history of successfully commercialising and managing pharmaceutical products worldwide.
Our out-licensing opportunities
We are currently seeking like-minded licensees for our Medical Nutrition range of products, and Laxido branded products.
Medical Nutrition
Galen offers a variety of innovative foods for special medical purposes, for use in the dietary management of inborn errors of metabolism.
No matter your situation, we have the industry expertise and global reach to promote, distribute, manage regulatory complexities, and commercialise your product.
Sales, Marketing & Launch Excellence
We excel in sales, marketing, and product launches to ensure your products succeed. Our sales team uses industry knowledge and strong relationships to effectively reach key customers. Our marketing strategies are data-driven, tailored to highlight your products' unique benefits, increasing visibility and demand. We manage all aspects of product launch, ensuring a smooth and impactful market introduction.
Our supply chain and logistics capabilities ensure your products are delivered efficiently and reliably. We manage all aspects of the supply chain, from procurement to distribution, maintaining high standards of quality and compliance. Our logistics team ensures timely and accurate delivery, minimising disruptions and maximising product availability.
Our regulatory affairs team ensures your products meet all necessary standards and compliance requirements. We handle the complexities of regulatory submissions, approvals, and ongoing compliance, reducing the burden on your team. Our expertise helps navigate regulatory landscapes efficiently, ensuring timely approvals and market access.
Our market access capabilities ensure your products reach the right markets efficiently. We conduct thorough market analysis, develop access strategies, and engage with key stakeholders to ensure optimal product positioning and reimbursement. Our expertise helps navigate market entry barriers and secure the best possible market access for your products.
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What our partners say?
Almeda Pharmaceuticals AG
“We believe that everyone should have the right to access appropriate health care. Finding innovative solutions to improve access to medicines and treatments is the biggest challenge for many patients today. Through our work with Galen and our commitment and daily efforts, we help people overcome this challenge and help them live longer and be healthier." - CEO Ala Tocarciuc
Interested in partnering with us?
If you have an opportunity for collaboration or an asset in one of our areas of interest, please get in touch with our business development team.
MAT-GAL-UKI-000244. Date of preparation: November 2024.
Interested in partnering with us?
If you would like to explore how our expertise could add value to your product, or for an initial discussion about partnering with us, get in touch today.
If you would like to explore how our expertise could add value to your product, or for an initial discussion about partnering with us, please contact our team.
