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Specialist pharmaceutical development consultancy for paediatric medicines

Jenny Walsh Consulting Ltd

Specialist pharmaceutical development consultancy for paediatric medicines

What we do

  • Jenny Walsh Consulting Ltd, founded in 2011, offers specialist pharmaceutical consultancy support, with a focus on paediatric product development, from early phase prototypes to products for marketing. 
  • Regulations in both Europe and the USA mandate the development of paediatric medicines for new products and incentives are in place for the development of off-patent (generic) paediatric products. However, there is still a global lack of licensed medicines for paediatric use.
  • The formulation of medicines for children can be challenging due to development differences in physiology and cognitive and motor skills compared to adults, leading to the need for medicines that are tailored specifically for them.
  • When formulating paediatric medicines, it is important to consider aspects such as patient acceptability, excipient safety and dose administration.
  • We work closely with clients in a flexible manner to assist them with their paediatric formulation programmes, to enable them to meet their business needs, patient requirements and regulatory obligations, as efficiently as possible.

Our services include

  • Provision of pharmaceutical formulation development consultancy support
  • Assistance with the selection of age-appropriate dosage form(s)
  • Review of excipient suitability for use in paediatric patients
  • Assistance with the design of medicine acceptability and palatability studies
  • Preparation and review of Quality sections of PIPs and PSPs
  • Assistance with PIP modifications, including responses to questions
  • Preparation and review of CMC regulatory documentation (IMPDs, INDs, MAAs, NDAs, PUMAs)
  • Assistance with responses to CMC regulatory questions
  • Preparation of CMC technical reports and summaries
  • Review of literature and authorship of scientific papers

Why choose Jenny Walsh Consulting Ltd

  • Extensive experience and recognised expertise in paediatric product development
  • Facilitates efficiencies and best practice
  • Enables compliance with regulatory requirements
  • Expedites the development of products that meet paediatric patient needs

About Us

Company Director Jenny (Jennifer) Walsh is a PhD UK-registered pharmacist ...

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Case Studies

Working as a "virtual" project team member in collaboration with the client ...

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Take a look at some of our reviews from our clients and our happy customers.

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Address East Midlands Chamber
8 Experian Way
ng2 Business Park
Nottingham, NG2 1EP

Telephone Number +44 (0)7757 948 052

Email Address

Company Reg No: 07753637