QUANTUM REGULATORY WRITING AND CONSULTING is a full-service, international agency dedicated to one thing only – regulatory affairs and pharmacogivilance, particularly the preparation of regulatory documents. Because we live and breathe regulatory affairs and pharmacogivilance we understand the complexities of preparation, filing/ registration and post filing/ registration needs. By simplifying workflow and streamlining processes, we can help you get more out of your next product filing or registration and clinical studies supporting data. It’s time to stop throwing money at the problem and start putting brains over budget.


QUANTUM REGULATORY WRITING AND CONSULTING provides full, professional regulatory medical writing,pharmacogivilance and consulting services to the pharmaceutical, biotechnology, and CRO industries in the United States, Europe, Russia and CIS countries. Full life-cycle support of documents from preclinical reports to regulatory submission documentation is provided.


Pharmacogivilance documentation such as PSURs and risk management plans also form part of the exceptional regulatory affairs services that QUANTUM REGULATORY WRITING AND CONSULTING provides.


Headed by physician, attorney and medical writer Lev G. Fedyniak, MD, JD and his pharmacist wife Olga Fedyniak, QUANTUM REGULATORY WRITING AND CONSULTING is built on quality, value, and service. Helping you meet your submission goals is our primary objective. We understand the need to get things done right. Being responsive to the client's needs and delivering quality projects on time and on budget are our priorities..