Reduce your development timeline with expert consultants

Produktentwicklungsberatung

Get an integrated strategy with operational oversight across all phases of your development program.

Reduce your product development timeline up to 30 % with programmatic outsourcing that eliminates the white space between development phases.

Apply our flexible, fit-for-purpose model that enables collaboration across several disciplines and unites multiple vendors and resources.

Identify time and cost savings throughout your development life cycle.

As part of Fortrea Consulting, Product Development Consulting offers a unique approach to compress your timelines and reduce costs. Instead of traditional, transactional "study-by-study" outsourcing-where knowledge must be transferred between vendors and phases-we've formed a unique product development team (PDT) and created a model that helps reduce time gaps between phases.

Throughout your iterative development process, we maintain our continuous scientific dialogue, adjusting to your latest product requirements as we integrate regulatory, clinical, medical, access and commercial strategies. By connecting and delivering cross-functional knowledge across our enterprise, we provide a holistic roadmap for your product and enable an end-to-end product development solution across local, regional and global geographies.

Providing support—when and where you need it

Working with our core Product Development team, our consultants can extend your team’s expertise as your program evolves with access across the Fortrea enterprise.

  • Regulatory Operations
  • Klinische Pharmakologie
  • Toxikologie
  • Pharmakokinetik
  • Wirkstoffmetabolismus
  • Genomik
  • Analytics/Informatics
  • Marktzugang

We can also work with your vendors or our proven partners to incorporate several other solutions and services into your overall program.

  • Bioanalyse
  • Therapiebegleitende Diagnostik
  • Biomarker Development
  • Zentrallabordienste
Creating a comprehensive partnership

We go beyond delivering consulting services to bring teams together across our business and yours. Our connections within clinical trial teams help form more collaborative relationships between roles and departments, such as:

  • Project Directors
  • Projektmanager
  • Clinical Leads
  • Klinischer Monitor
  • Study Start-up Lead and Specialists
  • Biostatistik
  • Medical Writing and Publishing
  • Datenmanagement
  • Behördliche Einreichungen
  • Vendor Manager Market Access

With these impactful partnerships, we aspire to increase efficiencies and help meet your unique product development requirements. 

Understand your path to success with a comprehensive clinical development plan.

Proactive planning and early engagement help you determine the best path ahead for your development program. We can provide an unbiased evaluation of your product through a clinical development plan (CDP), a tactical report and proposal that outlines how to mitigate potential risks, forming your foundation for success. We offer support and solutions for:

  • Target Product Profile (TPP): Define critical attributes and strategic objectives of your product along with the rationale for development spanning scientific, medical and commercial considerations
  • Compound Profile: Get a plan for your key CMC, pharmacology, toxicology, PK and ADME attributes, as needed
  • CMC, Nonclinical and Clinical Strategies: Understand the studies and approaches you need at each development stage 
  • Regulatory Strategy Consulting: Access strategic advice to help define and implement your regulatory development pathways 
  • Digital Health: Incorporate digital biomarkers, digital therapeutics and AI technologies into your development
  • Major Development Challenges: Anticipate key issues with mitigation strategies
  • Program Management: Get a comprehensive program timeline and integrated planning that outlines costs and resources to guide key decision points 
  • Systems Engineering: Enable risk management, usability/human factors, requirements tracing and verification/validation throughout your development process

Get expert support for your unique needs.

We can help guide decision making and execution for your drug product, medical device or cell and gene therapies by supporting your:

  • Pädiatrische Planentwicklung
  • Ausweisung als Medikament für seltene Krankheiten
  • Abuse Liability Assessment 
  • Ausweisung als Fortgeschrittene Medizinische Therapie
  • Diversity Plans
  • SAKIGAKE
  • PRIME
  • Expanded Access
  • Expedited Programs (Fast Track, Breakthrough, Regenerative Medicine Advanced Therapy RMAT designation)
  • INTERACT meeting 

From first-in-human through registration, we can enable more seamless transitions and ensure more efficient product development progression at the program level.  

Get in touch to enable critical path product development that reduces costs and accelerates your time to market.

Lassen Sie uns ein Gespräch beginnen