How To Choose the Right Out-Licensing Supplier for Your Generic Pharmaceuticals Business
It's crucial to have the right supplier for your out-licensing generic drugs business. Working with a company you trust, who is efficient, and meets all your relevant needs is important if your business is to run smoothly and efficiently. But just how do you choose a supplier? What factors are important to consider?
Good quality dossiers
You need a good quality dossier that will be approved in registration, one that is compliant with all regulations and guidelines. For this you need a reputable company, one that has vast experience with dossier registration, and won't get caught up in a lengthy back and forth with the authorities.
Expert regulatory team
Once the dossier is ready, the next step is obtaining a marketing authorization for the markets you want to sell in. While you can do this yourself or via a third party, the best option is if your out-licensing supplier can do this for you. Look for a company that has a proven record in securing regulatory approval prior to patent expiry. The more countries they've obtained MAs in, the better, as it will broaden your horizons too. If you know that you want to target many markets around the world, it’s vital for you to work with a company that can support you.
High quality products
At the end of the day, your goal is to serve your customers who are serving the end patient, so the product must be top quality. Quality and reputation are everything. How long has the out-licensing supplier been around for? Do most of their customers continue to collaborate with them after their initial contract is up?
A Competitive Price
Of course, price is key — you want to have control over your costs and expenses. But be mindful that ideally, you'll want this supplier to carry you through your whole commercial journey with this product, and hopefully other products too. And the commercial terms you agree upon with your choice supplier need to reflect not only the actual price but multiple other factors that will be crucial for you in the long term, such as product quality and the support you'll be getting from your supplier on day-to-day basis.
Experienced team of experts
What expertise does this company bring to the table? What teams do they have that will support your individual needs? Do they have a dedicated launch team who will get you to launch at patent expiry? Do they have the people and technology in place to comply with increasing requirements? It's vital to do some research to know who's in the company and how they will work together with you throughout your journey with them.
Reliable supply chain
Your customers have deadlines, so it's crucial that your out-licenser is reliable and can supply you on time. While, of course, internal and external factors (global pandemics and energy crises, to name a few) can affect the supply chain, the idea is that you collaborate with a company that supplies in full and on time! In the cases where they can’t supply on time, that they are fully transparent and keep you in the loop.
Communication is everything. Things can't always run perfectly, so it's so important the company you choose is constantly in touch with you and updating you with the status of your orders and any hiccups or challenges that need to be solved. It's a major advantage if the company has a dedicated customer experience person for you, someone who is easily contactable, knows your company and its needs, and has regular meetings with you to update you about your products and orders.
Extensive Portfolio of Products
Parnering with a company who has a large portfolio of their own will make it far easier for you to build up your portfolio of products to offer your customers. Working with one supplier is always easier than working with multiple. There will be less processes for you to learn and it will help you to maintain efficiency from an operational point of view. So, make sure to look for a company whose portfolio covers a broad range of therapeutic areas and dosage forms.
It's an added extra if your supplier produces its own active pharmaceutical ingredients. It makes the whole end to end journey of your product that much faster and smoother.
We hope this list of factors to consider when choosing your out-licensing suppler is comprehensive and helpful. If you'd like more information about Medis and the products and services we offer, please contact us.
Medis specializes in out-licensing high-quality generic pharmaceuticals to third-party pharmaceutical companies. Established in 1985, we offer a broad portfolio of 185 generic pharmaceutical products, mainly in the form of tablets, capsules and injections.
Our company is established as a reliable source of pharmaceutical intellectual property in the form of comprehensive registration dossiers. Our vast experience in launching new products together with our proven regulatory skills, enable us to achieve fast and successful results.