As your product approaches approval, the NDA team stands ready to support your product launch into multiple jurisdictions.
Some of the world’s most prominent brands have been supported by our team, ensuring efficient regulatory compliance and creative development strategies for those assets that are generating true value for patients and for your company.
Each Phase of Development comes with its own unique challenges. Read more about some of the challenges you will face during this phase and the NDA solutions by clicking on them below.
Challenge: Product Launch
Have you achieved marketing approval and are now gearing up for launch? Do you have a grip on the regulatory requirements in your target markets? Is your commercial team anxious to get going but you want to make sure that your promotional material follows your label and can be approved quickly?
NDA’s commercial products team ensures that your promotional material is appropriate, that your packaging meets the regulatory requirements and that your patient and physician information is accurate and up to date. Contact us today for a turn-key solution to managing your product on the market in the EU and the US.
Challenge: Orphan Drugs
Are you faced with particular challenges to manage and maintain your product in multiple markets? Is the complexity of your product making you hesitant to reach out to just anyone for support?
NDA’s commercial products team have specific experience in the special requirements and circumstances surrounding orphan products. We provide full-service regulatory support to clients in need of the specific expertise required to ensure the successful maintenance of these products in the market.
Challenge: Commercial Product Management
Is your product portfolio expanding? Is your regulatory team limited in capacity or capability? Do you need another pair of safe hands with significant experience of the challenges that you’re facing?
NDA’s consultants can operate as an integrated part of your team. Through full- or part-time packages we find cost-effective solutions when the portfolio is complex. Contact us when there just is not enough time to manage everything that must be managed.
Challenge: OTC Switching
Are you considering alternative revenue streams for your established products? Have you considered selling your product over the counter? Do you have a firm understanding of the regulatory opportunities and pitfalls for such strategies?
The NDA OTC switch team has successfully helped switch more than 30 products for different companies. This has enabled new sources of income and financing of new development programs. Talk to us about what opportunities you may already have in your portfolio to generate new income.
Creating real value
Your data is complete, your dossier submitted and you’re waiting for the verdict – will your product be approved for marketing or not?
It is only once your product hits the market that it starts to deliver on its promise – to treat patients to the fullest extent possible. And it is only at that time that you will realise the full value of your asset as it starts gaining traction, from launch through the necessary maintenance and development activities that go along with having a new product on the market.
Hitting the ground running
A good product launch doesn’t happen once a product is approved for marketing. A good product launch may be years in the making before the regulators hand you their seal of approval.
Preparing for launch is every bit as strategic as creating an optimal development plan. It starts with the product label, ensuring it captures the intended market and negotiating it with the regulators knowing what you can sacrifice and what is non-negotiable. Capturing this label in your launch material, executing swiftly to create your patient and physician information and packaging, as well as compliant promotional material, is essential to be able to rapidly move to market after approval.
At NDA we help you move from strategic planning and negotiation to operational excellence in one swift stride, ensuring your product hits the ground running.
Once out there, your product, your systems and your organization are under constant scrutiny and surveillance. Every change to your packaging, every adjustment of your manufacturing process, every new service provider – almost any change at all – may be the cause for a regulatory variation. Managing your products in the market, protecting your most valuable assets from regulatory, safety and quality related risks, is what the NDA commercial product team does best.
This is particularly true to those products that are different from the more conventional medicinal products. Complex biologics, often aimed at rare diseases and orphan indications, require a special mindset to manage. The hospital setting provides both challenges and opportunities for these treatments from a regulatory development point of view and our team thrives on solving these problems and seizing the opportunities for your product.
Keep on developing
Reaching the market doesn’t mean that your product stops developing. The wealth of real-world data, new indication opportunities and alternative commercial options, like Over the Counter switching, provides new development opportunities for your asset for years to come.
The NDA regulatory strategists bridge the commercial and development spaces and help your team see, assess and creatively execute alternative development scenarios. Through this approach we’ve helped dozens of companies extend the life of their premium assets for years and expand their revenue streams with impressive multiples. Not to mention the fact that ingenious innovation has been proven to help patients well beyond the original label.
It is only when your product reaches the market that it starts to deliver on its promise. Our team is committed is to ensuring that the best possible medicines reach the market without unnecessary delay and making sure that they remain there for as long as they benefit the patients.
Our services include
- Product launch support
- Legal entity establishment in EU
- RP GDP
- QMS development and implementation
- Label negotiations and implementation
- Promotional review
- Packaging and information inserts
- Readability testing
- Variations - Type I & II
- Extension and new indication strategies
- OTC switch assessment & execution
- Dedicated product & portfolio management
Your drug development needs are unique
Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.
Let's Bring Medicines to the World