Our team of regulatory experts and medical writers assist you in reporting new findings regarding your drug´s efficacy, safety, and optimal use. Our close interactions with national and international regulatory agencies along with our in-depth knowledge of worldwide post-marketing guidelines, requirements, and reporting procedures enable us to have the expertise and versatility to ensure that your post-marketing activities run smoothly and on schedule.
- Abstracts and manuscripts
- Design and management of REMS (Risk Evaluation and Mitigation Strategies)
We support your post-marketing surveillance regulatory compliance efforts by submitting to the appropriate authorities your newly acquired safety information including serious and unexpected adverse events associated with the use of your drug, and information on your strategies to manage the identified - or potential - risks (i.e. Risk Evaluation and Mitigation Strategies). As requested by the FDA, our regulatory experts and medical writers also manage your timetable for completion comprised of a set of milestone dates used to measure the progress of your study and compliance with regulatory requirements, and the submission of your periodic reports.