Jenny Walsh Consulting Limited
http://jennywalshconsulting.com
Jenny Walsh Consulting Ltd offers specialist CMC pharmaceutical consultancy support to pharmaceutical, biotechnology and healthcare industries and academia, with a particular focus on paediatric product development and technical writing. European and US legislation requires the development of medicines for children to be considered for all new products and incentives are also in place for the development of paediatric medicines for off patent products.
Jenny Walsh is a PhD pharmacist with over 15 years experience in pharmaceutical and consumer healthcare product development (GlaxoSmithKline, Napp Research Centre, The Boots Company, Reckitt Benckiser, and AstraZeneca). Her areas of expertise include the formulation of oral dose forms and paediatric medicines. She has extensive experience of reviewing and writing technical and regulatory documents including QOSs, CMC parts of MAAs, IMPDs, NDAs, INDs and more recently Paediatric Investigation Plans (PIPs).
The services offered allow customers to focus on their core competencies and meet their regulatory obligations. The provision of robust and realistic paediatric development strategies and plans will reduce the risk to adult product licence applications and lead to reduced overall development times and costs.