Services

The regulatory services we provide help pharmaceutical and biotechnology companies develop new medicines.

Our pre-approval services include:

  • regulatory planning and due diligence,
  • target product profile development services,
  • scientific advice and protocol assistance,
  • Priority Medicines initiative or Innovative Licensing and Access Pathway designations,
  • accelerated assessment, Fast Track and Breakthrough Therapy Designation,
  • paediatric investigation plans (PIPs),
  • orphan designations,
  • support for marketing authorization application (MAA) or new drug /biologics license application submissions,
  • medical writing services,
  • clinical protocol development, and
  • small or medium-sized enterprise support.

We often work on medicines (especially in oncology or orphan diseases) where the development plan is very different from the traditional model. This includes submitting MAAs based on: Phase 1 or 2 data; using basket or umbrella studies; and accelerated, conditional or exceptional approvals.

We can tailor our services to fit your needs.

Flexible regulatory services from start to finish.

Whatever your needs, we are your trusted life sciences partner:

  • Short-term (3–6 months), discrete projects to address a particular need for resources or expertise.
  • Long-term (12–24 months) projects, such as an MAA, new drug application or biologics license application.
  • Ad-hoc or complex development services such as regulatory due diligence, paediatric development or orphan designation if you are developing medicines for rare diseases.