Streamline the registration process for your pharmaceutical product in Asia with the help of our regulatory specialists.
The pathway to obtaining registration approval for drug products in Asia can oftentimes be lengthy and difficult. The regulatory agencies in each Asian country have their own unique set of regulations and requirements that must be followed, and any mistakes or oversights in your initial application dossier can lead to significant delays in the registration process.
Pacific Bridge Medical can help pharmaceutical and biotechnology companies find the most time- and cost-efficient way to apply for registration in their target Asian countries. We specialize in complex registrations and work with our clients to successfully obtain approval by offering the following services:
- Review the client’s product and establish the most effective approach to registration
We will closely study your drug product’s specifications and determine the necessary steps of the application process. In Asia, there are many regulatory requirements and potential pitfalls that are not clearly delineated in easily accessible resources and tutorials. Thus, a thorough understanding of the regulatory system and submission requirements in each Asian country is crucial to ensuring a smooth, successful approval process.
- If necessary, conduct a gap analysis of the client’s product
- Assess whether local clinical trials in Asia are required for the client’s product
- Prepare all the requested documentary requirements for submittal to the regulatory agencies in Asia
We will carefully review and prepare the application dossier, including materials regarding quality management systems, foreign manufacturer accreditation, etc.
- Respond to any questions or requests from the Asian regulatory agency
If in-person meetings are requested by the Asian regulatory body, we can attend the meetings on the client’s behalf.
- Provide the final registration approval certificate to the client upon receiving it from the Asian regulatory agency
To find out more about how we can assist you with the pharmaceutical product registration process in Asia, contact us now for a free consultation with our Asia regulatory experts.
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