Regulatory affairs is crucial for clinical trials as it navigates the complex landscape of global regulations, ensuring compliance, safeguarding patient safety, and facilitating the approval and successful conduct of trials.
The HiRO regulatory team offers end-to-end regulatory support, covering a wide range of consultations and submissions. This includes providing guidance and assistance in drug development plans, consultation meetings with regulatory authorities, clinical trial applications, life-cycle management activities, marketing authorization applications, license life-cycle management, common technology document preparation and submission, and due diligence processes.
With a combination of local experience and global standards, the HiRO regulatory team brings a wealth of expertise in non-clinical studies, chemistry, manufacturing, and controls (CMC), regulatory operations, registration strategies, and overall regulatory strategy. This diverse expertise enables them to navigate the complexities of regulatory requirements and streamline the product development pathway. By understanding both local and global perspectives, the team can effectively address regulatory challenges and optimize the regulatory strategy for successful market entry.
We combine local experience with global standards for non-clinical, CMC, regulatory operations/registration and strategy.
Our core regulatory team has an average of 18 years of experience across global and Chinese life sciences companies.
Strong local and global expertise due to broad experience completing non-clinical, CMC, regulatory operation/registration, and strategy throughout the product development cycle.
Our accumulated practical experience supporting regulatory consultations for innovative, generic, and biosimilar drugs in APAC, the US, and Europe has led to ongoing repeat business.
