Product Development

Boyds’ product development team is highly experienced in the development of medicinal products, working across a wide range of product types and spectrum of therapeutic areas.

The team is able to use its extensive experience to assist clients in planning and executing their development programmes, by providing strategic input and advising on or building an overall development plan for the product from concept, through pre-clinical development, to first-in-human and later-stage clinical studies, through to registration and beyond. Operationally, the Boyds team works closely with clients to oversee an agreed programme(s) or work, which may cover all aspects of development,  including manufacturing and analytical characterisation, pre-clinical studies and regulatory activities.

Boyds’ experience with advanced therapies enables us to innovate when faced with novel situations for which there may be no obvious development or regulatory precedent.

Examples of where Boyds Product Development Team can assist you, include:

  • Project leadership
  • Development strategy planning and execution
  • Management of programme timelines and resources
  • Selection of contract manufacturers and analytical labs
  • Identifying and subcontracting a consultant QP
  • Identifying pre-clinical CROs
  • Pre-clinical study design, placement and oversight
  • Identifying and subcontracting a consultant toxicologist
  • Clinical product development strategy
  • Selection of clinical CROs
  • Identifying and subcontracting a consultant biostatistician
  • Collaborate with Boyds’ regulatory team to provide regulatory strategy, prepare and submit regulatory documents/dossiers, and liaise with regulatory agencies
  • Support for commercialisation activities
  • Undertaking technical due diligence/technology assessments and support for in-licensing activities
  • Support for partnering/out-licensing, and fundraising activities
  • Support for partnering/out-licensing, and fundraising activities
  • Assistance with grant applications
  • Support for GXP auditing
  • Document QC services

Speak to a member of the product development team today