Regulatory Approval
Leveraging our experience to guide you through the regulatory approval process
The Asia-Pacific region is the fastest growing healthcare market in the world with a tremendous need for the latest medical treatments. We will help you achieve regulatory success to improve the health of the billions of citizens living in this dynamic region.
Most regulatory agencies in the Asia-Pacific (APAC) region require the submission package of ancillary and regional documents, following the approval in the major markets. Depending on the country, additional summary documents such as analytical method and validation, process validation protocol and report, drug substance master file, site master file, supplier, supply chain stability data, and others may be requested.
We will support you through the approval process in APAC including preparing for meetings with regulatory agencies, helping you draft responses for the agency review team, and being your representative in the process until the application is approved.
