Navigate the complicated regulatory systems in Asia with the assistance of our expert regulatory consultants.
Asia’s regulatory systems are diverse, and oftentimes challenging to navigate. The regulatory agency in each Asian country has its own set of regulations and customary manner of conducting business. Thus, determining the most effective and efficient strategy to obtain approval for your pharmaceutical product from each regulatory body without sufficient knowledge and experience with Asian regulatory affairs can be a very difficult task.
Pacific Bridge Medical’s approach to designing regulatory strategy employs our strong understanding of the Asian markets and regulatory systems to enable our clients to make confident, actionable decisions. We specialize in assisting pharmaceutical companies with their most difficult, complex endeavors in Asia, and can help our clients to develop intelligent solutions in all areas such as product registration, reimbursement, and local agent representation.
When crafting a regulatory strategy for your pharmaceutical product in each Asian market, there are four important questions that should be considered:
- Does your regulatory strategy incorporate an understanding of the constantly shifting requirements and regulatory environment in each Asian country?
The regulatory agencies in Asia frequently announce revisions and updates to their drug regulations. What are the newest regulations in each Asian country for clinical trials? How are the drugs classified? What are the documentary requirements for product registration? We always keep up with these changes in order to eliminate any uncertainty for our clients.
- Does your regulatory strategy account for potential issues that may delay the approval of your drug product?
Unwanted problems and obstacles that slow down the approval process for your pharmaceutical product may arise. We will help you proactively identify potential challenges and devise creative solutions to bypass and resolve these issues ahead of time, so that no unexpected issues interrupt the registration of your product.
- Does your regulatory strategy utilize the most efficient pathway to register your pharmaceutical product in Asia?
Our thorough understanding of the Asian regulatory systems can help our clients reduce the time and costs necessary to obtain product registration for their drug products. For example, in some cases, local clinical trials can be avoided, or the costs can be partially covered by your local partner. We will help you determine the most time and cost effective way to obtain approval for your pharmaceutical product.
- Does your regulatory strategy include a plan to obtain a competitive reimbursement price for your drug product?
In many Asian countries, procuring a high reimbursement price for your drug product is crucial if you want to compete with other products on the market. Our expert consultants will assist you with obtaining reimbursement status and a profitable reimbursement price for your pharmaceutical product.
To learn more about the regulatory pathway and registration requirements in each Asian country, please select your target market: China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, the Philippines, Singapore, Taiwan, Thailand, and Vietnam.
Contact us today for a free consultation with our Asia regulatory consultants on developing a regulatory strategy for your pharmaceutical product in Asia.
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