Late Development & Submission
Entering into the costliest phase of drug development requires a strong foundation – a foundation that we at NDA have been testing and vetting for hundreds of companies.
Once the course is set, preparation for filing commences – the largest regulatory challenge your product has yet to face. Do you want your product approved in the US and the EU? NDA is here for you.
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: Phase 3 Preparation
Did your Phase II trial go almost to plan? Have you managed to get financing to go into Phase III but want to make sure that your program is optimized to meet the needs of regulators across the Atlantic? Is there ambiguity in the data?
The NDA Advisory Board reflect the practices and views of the regulators better than any alternative and can ensure that your most expensive studies avoid false failures.
Challenge: Major Submissions
Are you anxiously awaiting the finalization of your pivotal study? Have you promised to deliver your product to market in the EU or the US? Are you fully aware of the efforts required to file for marketing approval in these two markets?
At NDA we support between seven and twelve major submissions (MAA/NDA/BLA) every year. This is more than any major pharmaceutical company. Talk to us about how to prepare for, and overcome, this major challenge in the best way for your company.
Challenge: Pre-Approval Inspections
Is your product approaching approval? Have your facilities not yet been inspected by the FDA or the EMA? Would you like to know that your quality management systems, procedures and actual practices are inspection-ready before risking a complete response letter?
NDA’s auditing and compliance team specialize in getting companies inspection ready. Our auditors cover the full range of GxP activities and offer you not just a second opinion, but a complete remediation plan to any issues that may be hampering your system. So that you can stand confident when the authorities arrive.
Challenge: Managing Safety Risks
How do you manage safety related risks? Are you considering how best to plan for and put a solid system for pharmacovigilance in place before you launch your product? Are you expecting the regulatory agencies to ask you to commit to monitoring or other activities after your product is launched?
NDA’s patient safety and pharmacovigilance team specializes in designing fit for purpose pharmacovigilance systems based on your product and patient profile. We support clients to achieve and implement meaningful, yet manageable, post authorization commitments. Talk to us about creating strong and efficient PV systems.
How can we help you?
The moment of truth
Late Development & Submission is the moment of ultimate truth – does your product do what you think it does? This stage is about confirming that those signals you saw so clear in early development are actual clinical effects of your treatment making an undisputable impact on the course of the condition.
Late development is also about bringing it all together, putting all of your hard-earned evidence into one big dossier – one that can be filed, processed and approved by the regulators set to safe-guard the population of the world.
Don’t go in blind
Your Phase III study is very likely the costliest endeavour that your team will embark on. Millions of your household currency will be poured into this program. With that in mind, not being fully prepared to ensure delivery in line with your expectations is just not the way you want to go.
The NDA Advisory Board comprises some of the most well renowned former regulators across the Atlantic. It better reflects the current practices and views of the regulators than any alternative and is ideally placed to offer your program a pressure test in a safe haven environment.
Experience is key
When Pharmacia once assessed key success factors in their development teams there was only one aspect that came out with clear statistical significance – those teams that already had successfully launched a product were prone to do it again.
The same is true for your marketing submission. At NDA we support up to a dozen major marketing submissions in the US and EU every year – more than any major pharma company. Our Principal and Senior Consultants have successfully led several MAAs/NDAs/BLAs and our publishing team has made well over 1000 electronic submissions since electronic submissions became a legal requirement.
Working as an integrated part of your team, we understand the “all-hands-on-deck-approach” that is necessary to win the day in time for your critical submission date. We do it together with you, and with us you know you stand the best chances of success in the world. Our track record speaks for itself.
Don’t play catch-up, be prepared
Once the end of your development journey is drawing closer, you start realising this is but a brief stop on a much longer journey. And the authorities will make sure to remind you of it.
One inevitability with approaching the market is the need for regulators to take a closer look at your manufacturing facilities to ensure that it’s not just your dossier that looks good, but that you can actually deliver the goods as well. For some companies, these authorisation inspections can put a real spanner in the works; if you’re not fully prepared, the regulator can put your launch activities on halt for a detrimental period of time.
At NDA we support companies through our inspection preparedness services where our experienced GMP experts take your team through the regulatory inspection process, identify the issues up front, and support you in identifying their root cause and appropriate measures to mitigate or fix them. When the inspector arrives, your problems will be fixed, or at least you’ll be well aware of what they’ll find and can talk to those points and your upcoming remediation plan.
Track, assess and learn
Finally, you must consider your safety commitments. Transitioning your company to be a commercial company, rather than a clinical stage biotech, is just as daunting and transformational as it once was shifting into the clinic. And even if this isn’t your first, every product has its own safety challenges, post authorisation commitments or quirky profile that must be addressed in your pharmacovigilance system.
We support companies negotiating and implementing meaningful, yet manageable, post authorisation commitments. After all that’s part of what an efficient pharmacovigilance system is all about.
Our services include
- Major submission management and preparation
- Electronic Publishing
- NDA Advisory Board program review
- NDA Advisory Board submission review
- NDA Advisory Board response review
- Post-authorisation commitments & surveilance systems
- Risk Management Planning
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.
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