Parexel has launched its Regulatory & Access consulting organization designed to optimize clinical development from the earliest stages. The newly formed Regulatory & Access team includes more than 1,000 on-staff consultants worldwide, including 100 former regulators and HTA assessors, to help navigate development and bring new therapies to patients.

“Today, achieving market authorization from a regulatory agency is only the first hurdle to a new therapy reaching the market,” said Paul Bridges, senior vice president, Regulatory & Access. “By more holistically considering the diverse requirements of regulators, payers and patients and aligning these insights with clinical development, companies can optimize their plans to drive smarter, more efficient and patient-focused strategies, leading to faster development and improved patient access to new medicines.”

Parexel’s Regulatory & Access consulting organization includes former regulators from global agencies including the U.S. FDA, U.K.’s MHRA and NMPA in China, therapeutic experts with technical expertise, market access specialists with health technology assessment (HTA) expertise for greater stakeholder engagement. The alignment of these capabilities aims to save time and resources across the drug development lifecycle.

“We understand the goal of every drug development program is to deliver results for a patient in need,” added Peyton Howell, executive vice president and chief commercial & strategy officer. “Our Regulatory & Access organization was designed with the patient in mind, helping companies advance through regulatory and market access hurdles without unnecessary delay in order to reduce the time that a patient must wait for an innovative new therapy.”