Development Optimization
We know your primary focus is on products, so maintaining a strong pipeline through innovative new science, and effectively managing development and commercialization are essential. Pharmaceutical and biotech consulting can help.
Innovation: Fueling product
and industry success
with Alberto Grignolo
| Case Study |
| A Targeted Approach to Clinical Development in the EU Market |
| Learn More > |
Product Focus to Maximize Product Results
PAREXEL Consulting provides its clients with data and insight to help shape product development plans: for pharmaceuticals, biologics, medical devices / combination products. We then provide expert resources to help propel your products over early stage hurdles, past key milestones, and on to first-cycle approvals.
Our ultimate motivation lies in helping you to advance the commercial success of your products, and to optimize the benefit they provide to patients in need.
Key Offerings:
- Comprehensive Product Development Strategy and Plan
- REMS, Reimbursement and Comparative Effectiveness Planning
- Regulatory Meeting Advice
- Scientific Advice
- Pediatric Development Plans, PIPs
- Regulatory and Clinical Trial Applications (INDs, CTAs)
- Regulatory Services to Fulfill Submission Requirements
- Submissions: NDA, ANDA, MAA, BLAs
- Product Acquisition, Integration and Licensing Services
- Portfolio Analysis
- Next Generation Product Development, e.g. Follow-on Biologics
Value Proposition:
By identifying the right product, design the right regulatory and market strategies and executing on them well, critical development milestones can be achieved, helping your company avoid loss of performance-driven payments or failed-out licensing.
You can also avoid the loss of product-revenue cost by increasing the likelihood of a first-cycle approval ($640M) or priority approval ($448M).* Product delay or failure can cost up to $23 million per day.** PAREXEL Consulting can help your company gain access to new markets enhancing company value.
Crucial patent exclusivity time can be saved via on-time approval, thus avoiding additional development costs due to delays or additional studies or other requirements. These costs can be as much as $37,000 per day.**
Contact Us:
For further information and to get in touch with our experts, please use our contact us form and type "Development Optimization" in the comment field. Thank you!
*PAREXEL Consulting Getting to Approval whitepaper published September 2008.
**Source: http://www.currentpartnering.com/articles/1051 Current Partnering, Pharma must adapt to changing market dynamics in 2008, April 2008.
