Regulatory Writing

Understanding the drug approval process and regulatory document submission is quite critical. At every phase of a clinical trial, a huge list of the documents is to be submitted to avoid any delays and penalties. Therefore, it becomes prime responsibility of the vendor company to provide the quality document on time.

We assure to get through the requirements well and providing the on-time delivery of regulatory documents. We suggest the appropriate way of going ahead even if the timelines have been missed and we work hard to complete the tasks even in tight timelines. We adhere to International Conference on Harmonization (ICH) guidelines to ensure the quality and completeness of the document. Our team deals with all documents for various regions of the globe and regulatory authorities including USFDA, EMEA, MHRA, TGA, ANVISA, MHLW and ROW.