Expanding distribution
to maximize product investments

Biopharmaceutical companies that have acquired new products for distribution are constantly seeking opportunities to maximize the return on their investments.  One proven way to increase sales is to introduce the product into additional markets around the world.  A proactive multi-country regulatory filing strategy helps any company expand the distribution of its products by accelerating global product introductions while avoiding regulatory pitfalls.  By understanding the differences in regulatory processes for countries around the world, and taking advantage of time-saving efficiencies such as the Common Technical Document (CTD), biopharmaceutical companies can significantly improve the speed and efficiency of  introducing their products into new markets. 

Although the CTD makes multi-country filing easier, regulatory submissions in the EU, the US, and elsewhere in the world continue to have significant differences, and the documents must be adapted to meet each region’s requirements.  Local knowledge of regulations and reimbursement policies is crucial to the success of any multi-country expansion strategy.  Familiarity with these differences in advance of preparing a submission can mean the difference between a smooth expansion process, and significant delays or failures. 

With our network of offices in 54 countries and extensive knowledge of multinational clinical and regulatory requirements, PAREXEL is in the right position to help biopharmaceutical companies develop a strategic product expansion plan by identifying key target markets, understanding important regional differences, finding the best local resources, and creating a robust CTD.  Our strategic multi-country approach will maximize the return on your product investments and help you get your important therapies to patients who need them around the world.

PAREXEL’s global market expertise includes:

• Marketing, pricing, and reimbursement analysis
• Regulatory filings and submissions in new markets
• Medical writing
• Worldwide labeling services
• Annual regulatory reporting
• Reimbursement strategies to maximize patient access
• Manufacturing resource planning