As a result of the introduction of Regulation (EC) No. 1901 & 1902/2006 all companies wishing to submit a Marketing Authorisation Application (MAA) for a new medicine must also submit a Paediatric Investigation Plan (PIP) for an equivalent paediatric formulation or obtain an exemption. The granting of a paediatric indication gives an additional 6 months patent protection.

Off-patent medicines supported by a PIP and an appropriate paediatric formulation can now be licensed for a paediatric indication in the EU via the Paediatric Use Marketing Authorisation (PUMA) route, which affords 10 years data protection.

Let Penn support your every step of the way with your Paediatric drug development and clinical trial needs. Penn's services support a fast and effective route from clinic to market. Penn has over 20 years experience in producing paediatric medicines.

Services:

• Paediatric Formulation Development
• Clinical Trial Supply Manufacturing
• Clinical Trial Supply packing, labelling, QP Release, distribution and reconciliation
• Manufacturing Scale Up - from pilot to commercial batch sizes
• Manufacture of paediatric Specials

Paediatric Formulation Capabilities:

• Oral Liquids - sugar-free; colour-free; alcohol-free; range of flavours
• Experts in poorly soluable compounds
• Orodisperable (fastmelt) tablets - sugar-free; colour-free; alcohol free; range of flavours
• Non-patent technology, accessible and affordable
• Buccal Liquids - for rapid buccal absorption
• Powders - dry powders or powders for reconstitution
• Topicals - creams, ointments and gels
• Suppositories

• Article - Children on Board - by Dr Rob Harris (1400k)