From initial R&D to regulatory approval, companies invest more than a decade of time in individual pharmaceutical campaigns. On average biologics require just over 10 years to gain regulatory approval with cell and gene therapies averaging 12-15 years for approval.

Given these timescales, it is unsurprising that less than 10% of phase 1 programs make it to regulatory approval. Many programs fall short of regulatory approval not because the technology is lacking, but because programs are mismanaged along the way.

At TKD we are confident that our clients’ technologies are best in class and ready for market, and we will not allow our clients’ technologies to fall short of regulatory approval due to project mismanagement.

We can help get you to market by managing aspects of the program that others may overlook. We will prioritize risk assessment, supply chain, budget and regulatory responses to streamline your path to approval.

We can create project plans for de-risking a program early and set timelines with checkpoints for validation, scale-up, and batch releases. We are well-versed in budget tracking and planning for clinical expense and supply chain demands. We can work with your team to meet program deadlines by advising on team organization, reporting and project deliverables.

We strongly believe that when projects are 10-15 years long, it is imperative to have knowledgeable and experienced project managers who can foresee potential risks in a program and streamline the path to approval, and at TKD we have those experienced project managers available to fit the needs of your project.

  • Project Plans and Schedules
  • Team Organization
  • Meeting Management
  • Action Item Tracking
  • Budget Tracking
  • Project Status Reporting
  • Risk Management

Plug in one of our Project Management experts to your team.

Nonclinical / Early Phase Development Process Development Regulatory Affairs Cross-Departmental Support Analytical Development Project Management Manufacturing Science & Technology Nonclinical / Early Phase Development Process Development Manufacturing Science & Technology Analytical Development Project Management Regulatory Affairs Cross-Departmental Support