Integrated Product Development

Regulatory strategy

Our Regulatory consulting team help expedite the drug development process. Our highly experienced team, including former regulators, provide expert advice on:

  • potential approval pathway(s), including expedited approval
  • review of precedents with similar products
  • proposed Regulatory agency interactions and support with Scientific Advice meetings, including storyboarding and preparation of the briefing documentation

Clinical development consultancy

Our Clinical Development Consultancy is a highly flexible service where we provide our clients with access to industry-leading expertise to support first time in human clinical development planning, from discovery through to the clinic. Our support can range from an interactive development workshop to providing flexible project leadership with access to specialists covering:

  • Regulatory Strategy
  • Translational Science
  • CMC
  • GLP/Tox
  • Medical Science
  • Data Science
  • Advanced Therapies

For us, one size never fits all. Our flexible approach makes our expertise available to clients of all sizes and at all stages of their drug development process – and our expanding global footprint means we can conduct trials in a growing list of countries.

We lead the industry in early phase and complex trial protocol design with the goal of obtaining the data needed to take forward to the next trial stage, and we are adaptive and agile in managing the challenges inherent in any clinical study.

Trial protocol design is critical to optimise success.