Consulting Solutions Designed to Extend Your Resources
As the costs to develop drugs continue to rise, biotechnology and biopharmaceutical 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 development to commercialization – you’ll gain a strategic vision and expert execution to advance your program.
Our comprehensive consulting solutions include:
- Prospective planning of Lead Optimization, Safety Assessment, Metabolism and Analytical study services
- Animal model evaluation and selection
- Full IND/CTA-enabling Program Management
- Nonclinical Regulatory Strategy
- Late-stage nonclinical strategies – including DART and CARC timing/planning
- Clinical Strategy
- Regulatory Strategy
- Target Product Profile
- Clinical Development Plan
- Medical Writing & Publishing
- Chemistry & Manufacturing Controls (CMC)
- Evidence Generation
- Access & Strategy
- Value Communication
- Maximizing Asset Value
Reveal Efficiencies With Relevant Consulting Experience
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. With our 250 collective interactions with global health authority 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.
Consulting That Creates the Right Results
While scientific 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 nonclinical, clinical and commercial development programs.