Having a pediatric strategy is crucial in the clinical development of any drugs with potential relevance to this population – even if the drug sponsors plan to develop primarily for adults. We’ll help you factor this in from the outset.
Without a pediatric development plan you may be unable to apply for marketing approval in some jurisdictions. For the EU, such a strategy is defined in a pediatric development plan (PIP) which must be agreed before the primary dossier is accepted. In the US, the requirement is for specific pediatric study plans (PSPs). We’ll make sure you’re prepared for all eventualities.
Leaving nothing to chance
We’ll help you build in a pediatric strategy and plan from the start, to secure a waiver or approval of your plans for a pediatric population. Having a pediatric development plan will also strengthen your development program overall.
Our emphasis on an integrated product development plan will ensure you consider any pediatric-specific needs early on in your development activity and that these become part of your broader strategy.
Get In Touch
Steering your product strategyWherever you are on your journey as a biotech – whether you’re still forming your team or seeking funding or putting together marketing authorization submissions – we’ll apply our deep industry and regulatory expertise to optimise your opportunity. We can help you across every stage of your product and business lifecycle, spanning:
Regulatory Agency Interactions and Clinical Trials
Non-Clinical and Quality
Establishing a Strategy
Due Diligence and Partnering
Insights HubSharing insights, questioning norms, asking the right questions - we'll never lose sight of what you're striving for. Our insight and expertise will help you bring the most innovative therapies within reach of patients around the world.
Planning for CBER and EMA success with cell and gene therapy
By Cori Gorman, Ph.D. The fields of cell and gene therapy are enormously promising while
News & Events
Start a conversation today
If you’re developing something truly ground-breaking, Biopharma Excellence is the nearest resource you’ll find to someone who’s been there before.