Certara’s medical and regulatory writing consultancy continues to improve its ranking over the past four years
PRINCETON, NJ – Aug. 29, 2016 – Certara®, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that Synchrogenix, its medical and regulatory writing consultancy, has been named to the 2016 Inc. 5000 list of the fastest-growing private companies in America. This is the fourth year in which Synchrogenix has received this honor.
“Synchrogenix has evolved from a regulatory writing and communications organization to a strategic, technology-enabled consulting powerhouse that is addressing the industry’s greatest regulatory challenges,” said Certara CEO Edmundo Muniz, MD, PhD. “The demand for Synchrogenix’s services is growing dramatically worldwide as sponsors recognize the hidden value that expert writing guidance can provide across the entire drug R&D and commercialization continuum.”
Synchrogenix brings a holistic approach from data through life-cycle management, addressing various audiences across the life sciences. Synchrogenix has mastered how to efficiently and accurately generate all the documents required for submission to global regulatory agencies and scientific forums. In addition to its expert team, Synchrogenix’s Artificial Intelligence technology platform uses natural language processing to create initial drafts of regulatory documents and anonymize confidential information in response to the European Medicines Agency Policy 43 and Policy 70.
Synchrogenix has already completed 12 regulatory submissions out of a planned 27 for 2016. Those submissions include investigational new drug applications, new drug applications, and biosimilar and generic drug applications for half a dozen regulatory agencies and numerous biopharmaceutical companies.
“For over 30 years we have focused on this specialized service because we know the value of strong and conscientious writing leadership. Our tremendous growth over the past five years speaks directly to the increased demand for strategic writing and clinical data transparency services. We have made very deliberate decisions as we grow to ensure that we are not only poised to meet the evolving needs of our clients, but also the needs of our staff, by maintaining a caring and team-oriented environment,” said Synchrogenix President Kelley Kendle. “Synchrogenix, in collaboration with the larger Certara family, has the unique understanding of the use of modeling and simulation as well as other novel approaches enhancing the drug development continuum. As with our Artificial Intelligence technology platform, we will continue to bring innovative offerings to the marketplace and grow our exceptional team.”
Synchrogenix works with pharmaceutical, biotechnology, and medical device companies worldwide. It serves Fortune 500 and smaller companies through its offices in North America, Europe, and Asia.
Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies.
Lauren Sobocinski, 302-892-4800
Director, Client Services
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions