MediPharm International Consultants is capable of helping your company, no matter what country you are located in. We Have a long standing and successful record of providing individualized support to our clients which will improve your chances of acheiving your project goals when dealing with the FDA. Whether it is the establishment of new quality systems, supporting an existing quality or regulatory system, final assembly of an electronic common technical document (eCTD), or responding to questions from the FDA, we maximize your opportunity for success. 

We regularly represent clients at critical meetings with the FDA. With our expert strategic advice and high-quality submissions, you will have access to the widest market in the shortest time. Our knowledge and global contacts help us expedite products through clinical trials to market. We are well versed in new chemical and biological registrations, the development of new medicines containing established active ingredients, generic submissions and post-approval activities. For smaller organizations, we often serve as virtual quality and regulatory departments, providing expertise as required while avoiding the expense of a full-time staff. 

We have completed hundreds of eCTD and CTD regulatory submissions in the following areas: