As the Chinese market for drug products is expanding along with the further Reform and Opening of China, more and more overseas pharmaceutical companies are searching for their opportunities on the Chinese market for further business development. As well known, the first step into the market is to apply for the drug registration. However, the Chinese laws and regulations for drug registrations are relatively different from which of other countries and regions. For this particular reason, a large number of overseas companies have encountered various difficulties in their applications for drug registrations. ACCESTRA CONSULTING has heard your voice and is fully prepared to assist in your China application. We will help you not only obtain the market approval for your product but also develop the market in various aspects of business. We have a team of experts with international experience. Regardless of your product type, drugs, active pharmaceutical ingredients (APIs), excipients or packaging, we can find the optimum registration pathway for your product. Based on our comprehensive interpretation of legal requirements and customized dossier analysis, we can minimize your budget, time cost as well as the risk of rejection, and finally obtain the market approval for your product.
The specialties of our regulatory service are:
- Our technical experts can provide a comprehensive analysis of your dossier and an individually optimized registration strategy.
- As Chinese regulations and provisions are under frequent change and development, we are always aware of updates in legal requirements, and therefore minimize the risk of rejection and avoid format deficiencies for your product registration.
- Our technical and linguistic experts can interpret all the legal requirements for your better understanding, translate your dossier with high accuracy in pharmaceutical aspect and guarantee the success in your product registration.