Pharma Product Development
Partner with Boyds to drive your drug development program forward with our pharma product development expertise.
Our 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 programs, 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 program(s) or work, which may cover all aspects of development, Â including manufacturing and analytical characterization, 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 program 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.
Get in touch
If you would like to talk to a member of our team about a specific project or area of expertise, then please complete this form and we will get in touch.
