製品開発
Save time and costs throughout your development life cycle.
Accelerate your product to market with our expert consulting services. We integrate regulatory, clinical, medical, market access and commercial strategies to streamline your development process and reduce costs.
Get an integrated strategy
Benefit from a holistic approach that combines cross-functional knowledge across all phases of your development program.
Shorten your development time
Eliminate white space between development phases with programmatic outsourcing that keeps your project moving forward.
Flexible, fit-for-purpose model
Collaborate with a dedicated team that unites multiple vendors and resources.
Compressing timelines—reducing costs
Our product development team uses our in-house model that reduces gaps between phases, compressing your timelines and reducing costs. We avoid traditional, transactional outsourcing and maintain continuous scientific dialogue throughout your iterative development process, adjusting to your latest product requirements as we integrate regulatory, clinical, medical, access and commercial strategies. By integrating deep cross-functional knowledge, we provide a holistic road map for your product.
Comprehensive support—collaborative partnership
We integrate the key roles and functions across regulatory, clinical, medical, access, data sciences and commercial to streamline your development process, reduce costs and accelerate time to market for your product. Working with our core product development team, our consultants extend and enhance your team's expertise. We go beyond consulting to foster collaboration between teams across our business and yours, ensuring efficient and effective product development.
Our extensive solutions
Working with our core Product Development team, our consultants can extend your team’s expertise.
-
Connect across our enterprise
The Fortrea Product Development team works closely with:
- Regulatory Operations
- 臨床薬理
- 毒性学
- 薬物動態
- Drug Metabolism
- ゲノミクス
- Analytics/Informatics
- マーケットアクセス
-
Incorporating complementary services
Our team can work with your vendors or our proven partners to incorporate several other solutions and services into your overall program, as needed.
- 生物分析
- コンパニオン診断
- Biomarker Development
- セントラルラボサービス
-
Expert support for your unique needs
We guide decision-making and execution for your drug product, medical device or cell and gene therapies, supporting your:
- 小児科向けの企画開発
- Orphan drug designation
- Abuse liability assessment
- Advanced medicinal therapy designation
- Diversity plans
- SAKIGAKE
- PRIME
- Expanded access
- Expedited programs (Fast Track, Breakthrough, Regenerative Medicine Advanced Therapy RMAT designation)
- INTERACT meeting
Chart your path and de-risk your program
Proactive planning and early engagement determine the best path for your development program. We provide an unbiased evaluation of your product through a clinical development plan that outlines how to mitigate potential risks:
- Target product profile (TPP): Define critical attributes and strategic objectives
- Compound profile: Plan your key CMC, pharmacology, toxicology, PK and ADME attributes
- CMC, nonclinical and clinical strategies: Understand the studies and approaches
- Regulatory strategy consulting: Access strategic advice for regulatory development pathways
- Digital health: Incorporate digital biomarkers, digital therapeutics and AI technologies
- Major development challenges: Anticipate issues with mitigation strategies
- Program management: Get a comprehensive timeline and planning for costs and resources
- Systems engineering: Enable risk management, usability/human factors and verification/validation