Drug Development Consulting Services

Leverage our experience to extend your resources.

As the costs to develop drugs continue to rise, biotechnology and pharmaceutical companies alike are seeking ways to increase their throughput without increasing fixed costs. Decreasing R&D spend can be achieved through several flexible CRO partnering models, which have evolved to meet the unique demands of today’s drug development landscape. 

An adaptable, fit-for-purpose consulting partnership can deliver results specific to your phase of development and company requirements. Whether you seek regulatory advice or support across the spectrum – from early clinical development to commercialization – you’ll gain a strategic vision and expert execution to advance your program.

Fortrea’s team of expert consultant include over 150 regulatory affairs professionals in more than 13 countries, to partner with you on solutions such as:

Clinical development
  • Clinical, Non-Clinical & CMC Strategy
  • Regulatory Pathways & Strategy
  • Target Product Profile
  • Independent Scientific Review & Gap Analysis
  • Clinical Development Planning
  • Agency Interactions Support
  • Medical Writing & Publishing

Specialized services
  • Pediatric Plan Development
  • Orphan Drug Designation
  • Abuse Liability in CNS Compounds
  • Advanced Medicinal Therapy Designation

Commercialization & market access
  • Evidence Generation
  • Access & Strategy
  • Value Communication
  • Maximizing Asset Value

While scientific, regulatory and operational expertise is essential to any consulting engagement, the foundation of a consulting relationship is built on a solid communication. We take the time to listen and fully appreciate your unique needs in today’s competitive market.

Let’s form a strategic partnership that enables you to achieve your goals and creates maximum value for your clinical and commercial development programs. Learn more about how Fortrea can help you optimize the market potential for your product.

Increase your probability of regulatory approval.

As global regulatory requirements continue to evolve, our expertise helps you stay ahead of the curve. With regulatory affairs professionals in more than 13 countries, Fortrea can help you navigate regulatory requirements throughout your product’s development lifecycle to support country-specific or worldwide registration.

With our 250 collective interactions with global health authorities and agencies, and more than 1600 IND/CTA submissions in the last 6 years, you can count on partnering with a consulting team that truly understands the hurdles of drug development.

Reveal efficiencies through collective knowledge.

When seeking support through consulting, you need a team that has a proven track record to overcome challenges, expedite timelines and deliver innovative solutions.

To help position your product for commercial success, leverage our team of industry experienced and specialized advisors for focused guidance. You not only gain access to a wealth of collective knowledge across many functional and therapeutic area backgrounds, but also an evaluation of your options and recommendations for your decision making at each critical development point.

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