Regulatory Consulting for Product Globalization
In today's marketplace, biopharmaceutical and medical device companies leverage the global environment to develop products efficiently and gain market advantage, as well as return on investment. While opportunities abound, it is a complex playing field with many challenges.
As of January 2010
New EU Commission
Regulations:
VARIATIONS
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Product Development Plans:
With the globe in mind
with Alberto Grignolo
| Case Study |
| Implementing Comprehensive Processes for Regulatory Support |
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Thriving in Global Markets
Having sound global product and portfolio strategies and leveraging specialized expertise and local resources are essential for success. Companies need to prioritize their portfolios, including how and where to focus which products and which regulatory and clinical paths to take. They must develop a business case that evaluates costs and product potential and the associated risk / benefits.
As a leader in global development services, executing hundreds of CTAs and CTD/NDAs and global GCP/GMP audits per year, PAREXEL Consulting can help speed time to market and promote long-term product / portfolio viability.
Key Offerings:
- Market Intelligence
- Product Global Expansion Strategy
- Pharmaceutical Regulatory Consulting Agency Advisory and Liaison Services
- Clinical Trial Applications (INDs, CTAs, CTNs)
- Full or Partial CTD / NDA / BLA
- Comprehensive Labeling Services
- Clinical Development Consulting
- GCP and GMP Audits
- PAI Inspection Readiness
- Product Acquisition and Licensing Services
- Portfolio Analysis
- New Product Acquisition Support
- Post approval lifecycle management
Value Proposition:
Enhanced speed of patient recruitment and the potential for lower cost of clinical trials are just some of the benefits your company will reap from global product development. PAREXEL Consulting will help your company leverage existing submissions for basis in other markets, and take advantage of enhanced speed for approvals and first cycle approvals.
Product globalization is also beneficial for managing the risk of product failure, avoiding approval delays due to non-compliance, and for achieving effective regulatory partnering (outsourcing) to drive efficiencies and pipeline productivity. Companies that partner with PAREXEL Consulting can take advantage of brand extension to new markets, and benefit from informed decision-making through effective due diligence of acquisitions, partners, and suppliers.
Contact Us:
For further information and to get in touch with our experts, please use our contact us form and type "Product Globalization" in the comment field. Thank you!
