PHDS acts as a local agent in China for the drug registration, API registration, excipient registration and packaging material registration for global manufacturers. By performing gap analysis, evaluating potential risks, identifying and correct deficiencies of the original documentation based on current requirements in China, PHDS is dedicated to provide more than dossier compilation, but an end-to-end regulatory affair services with premium quality.
Experienced Regulatory Affairs Leadership
PHDS can help improve the likelihood of product authorization by regulatory authorities. Our experienced professionals can:
● Provide strategic development advice and targeted assistance
● Facilitate the development of effective product labels
● Develop competitive intelligence surveys
● Define and refine regulatory development plan content
● Represent or support interactions and negotiations with regulatory authorities
Trust in the Leading CRO in China
PHDS brings more than 20 years of experience in China and a reputation as a preeminent contract research organization (CRO) in China to help you navigate the evolving Chinese regulatory landscape and get your products into China faster. We leverage strong relationships with authorities and in-depth knowledge of Chinese regulatory processes and timelines to help you identify the best approach to keep your submissions on track, saving you critical time and money.