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.
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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:
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What a year! Biopharma Excellence has been easing the path to market for a whole host of advanced therapies and biosimilars
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