ABSTRACT
Asia-Pacific is a widely diverse region with a complex and rapidly changing regulatory environment. The way to overcome these hurdles is to incorporate the regulatory strategy into the business planning and turn what was perceived as a burden on the organization into a strategic advantage. It is undeniable that a fast and well-executed product launch will provide a company with the advantages of being the “first-mover” on the market: relatively easy acquisition of market share, higher initial profitability, positive impact on brand image, and opportunities to shape the market. A regulatory strategy can do more than supporting the entry of a product into a market. A stronger strategy will simultaneously plan to make it more difficult for competitors to follow with their products on the market. Continuity of business is best achieved through anticipation and planning: anticipation of a change of regulatory status of an existing product, or anticipation of a change in the regulatory landscape.
