Bringing a new drug, biologic, or medical device to market is among the most complex regulatory journeys in any industry. Systematic Reviews, LLC serves as your strategic regulatory partner — mediating between your organization and the regulatory agencies that govern market approval in the United States, Europe, and Japan. We understand the expectations, evolving guidance documents, and decision-making frameworks of the FDA, EMA, and PMDA, and we translate that knowledge into submission strategies that are scientifically defensible, procedurally sound, and positioned for success.
Our regulatory affairs division manages the full spectrum of submission requirements across all major global markets. In the United States, we prepare INDs, NDAs, BLAs, 510(k), and PMA applications. In Europe, we support MAAs to the EMA and national competent authorities. In Japan, we assist with PMDA submissions. Our team handles all required documentation — clinical study reports, investigator brochures, risk management plans, benefit-risk frameworks, and pediatric investigation plans — with the precision and regulatory fluency that complex submissions demand.
We understand that regulatory timelines do not pause for resource constraints. For pharmaceutical companies, biotechnology firms, and CROs managing multiple simultaneous programs, we offer flexible, high-quality overflow and outsourcing regulatory support. We integrate seamlessly with your internal processes, operate under your SOPs, maintain strict confidentiality, and deliver to your quality standards — on time, every time.
Regulatory documents are produced by medical doctors, regulatory scientists, and medical writers with relevant submission experience, engaged per project and matched to therapeutic area. We maintain current awareness of evolving FDA, EMA, and PMDA guidance and bring that regulatory intelligence to every engagement.
Full preparation for FDA across drugs, biologics, and medical devices.
MAAs for Europe and regulatory submissions to Japan's PMDA.
CSRs, IBs, RMPs, benefit-risk frameworks, PIPs, and all supporting documents.
Confidential regulatory writing under your SOPs for high-volume or time-sensitive needs.
Whether you need regulatory submission support, medical communications, scientific publications, CME development, or wish to join our free systematic review authorship program — we are ready to work with you.