Regulatory Affairs Consulting
Taking the Lead on Compliance and Effective Communication
New markets and changing regulatory criteria make well-informed regulatory affairs professionals indispensable to pharmaceutical and biotech companies during each phase of clinical testing and regulatory submission. GlobalSubmit’s regulatory affairs team meets the growing demand for professionals able to advise on clinical strategies, manage content, ensure technical compliance, and communicate with health authorities.
Our regulatory affairs professionals are available to quarterback the entire lifecycle of your clinical testing and regulatory submission, acting as the focal point for data and discussion with internal and external contacts. In addition, we oversee preparation and provide support for health authority meetings including requests more detailed information.
Working in tandem with GlobalSubmit’s Submissions Management suite, an engaged regulatory affairs department ensures effective communication with health authorities while providing you peace of mind. Our regulatory affairs services are also available on an as-needed basis to complement in-house staff during peak workload periods.
GlobalSubmit’s full complement of services and software platforms affords a sponsor the luxury of dealing with one vendor during the lifecycle of a drug submission. Such an arrangement improves communication internally and externally, standardizes data formatting and streamlines the submission process.