Paediatric Plans
Sharp Regulatory has experience in designing and submitting paediatric development plans. Specific legislation and regulations exist in the United States and Europe, which state that the paediatric population must be considered and addressed within a product’s development plan. The challenges imposed by the FDA and EMA for paediatric data are well known to pharmaceutical companies and Sharp Regulatory can support your paediatric efforts with services ranging from consultation on program design to meeting with the regulators.
Getting in touch
If you would like to have an initial conversation about your requirements please contact Angela ……
Mobile Number: +44 (0)7738 971523
Email: [email protected]