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.
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 so we can assign the right expertise for further discussion.
*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.