There's a great opportunity to improve your decision making, make clearer and smarter priorities, streamline your development activities and reach the market faster.
It's spelt Regulatory Affairs.
A major business opportunity
From the early phases of clinical development, initiated by your first-in-human trial, through the entirety of your product’s life cycle, regulatory interactions are essential to your progress and success. These exchanges will shape not only the advancement of your program, but the value of your asset and your company.
At NDA, our job is to work with you to maximise the opportunity of these key interactions and submissions based on our extensive experience, so that you leverage the full potential that the regulatory systems have to offer.
Greenlighting your clinical program
You are planning your clinical program, including trials in the US and in the EU. This is an exciting journey for you and for the CRO supporting your activities. At this stage of the process, it is desirable to also partner with someone who understands the regulatory environment in the jurisdiction you’re entering into. A partner that can act as an objective advisor and the center of excellence for your operational regulatory activities.
Having NDA’s regulatory experts on your side throughout the submission process means that they can ensure swift execution of the application, as well as timely and competent responses to any question or concern that might raise. This way, NDA offers the perfect complement to the CRO partnership you already have in place.
Engagement is a two-way street
The best way to move forward is often to engage directly with the regulator. Through accelerated pathways, scientific advice or other formal mechanisms the world’s most prominent regulators offers opportunities for discussion, debate and negotiation regarding requirements, guidelines and, importantly, the science behind your product. But even in the day-to-day activities, appropriate interactions with the right regulatory representatives can be hugely beneficial to drive your progress and overcome minor setbacks.
NDA has supported numerous formal scientific meetings between companies and regulators under very different contexts and facilitated the most ideal outcomes for both parties in this exchange. For the successful companies, this has meant meeting minutes that have a direct impact on the evaluation of the asset and the company. For the regulator, it has meant a more thorough understanding of the science and clinical significance of the treatment.
Demonstrating your ability to serve patients
You have the data and it is time to demonstrate that your product and your company is ready to serve patients. The regulatory dossier is more than a binder of data – it’s the full body of evidence as well as your argument for approval. Having the right data is crucial but drawing the right conclusions from the data and presenting these in a compelling and understandable way is equally important. Managing this process in dialogue with the regulator, the CRO and your team is what we do best at NDA.
The whole process can last for years. Proactive compilation of sections of the dossier can start early and the earlier you start, the easier it will be to plan and predict the process. At NDA we manage between seven to a dozen major filings every year and our publishing team has published more than 1 000 electronic submissions since 2007 when they were mandated. We’ve got the process covered – from the tactical management of the procedure and the necessary regulatory interactions, through to the compilation and execution of the actual submission.
Is This The End?
The marketing authorisation is not the end, but a crucial milestone for your product and possibly a transformation point for your company. Regulatory management of a commercial product is its own speciality. Every change you want to make to your product, from formulation changes and new indications through to changes to packages or inserts, may require a regulatory variation.
NDA’s commercial product team specialises at the fine craft and science behind protecting your products in the market as it is now they are truly starting to deliver on their full potential, treating patients and generating revenue. From product launch through management of every regulatory variation we are there to support you. From promotional review and packaging design, to continual electronic variation submissions, we handle your activities for the US and European market.
And should your product really meet the end, we will handle that as well, making sure it can be withdrawn from the market in as cost-effective a way as possible.
Our services include
- Scientific Advice / Protocol assistance preparation
- Paediatric Investigation Plans
- Orphan Drug Designation Application
- SME support
- Clinical Trial Applications
- Pre-IND/IND submissions
- Acceleration strategies & Expedited Pathways
- Major Submission Management and Preparation
- Product launch support
- Promotional review
- OTC switch assessment and execution
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