Connect with the experts who've shaped the landscape
Our team comprises former regulators and health technology assessment (HTA) professionals who have played a pivotal role in establishing the very standards you are striving to achieve. We navigate global regulatory submissions, lead compliance activities, devise market access strategies and plan product launches. To maximize the market reach of your assets, we support global regulatory submissions and provide ongoing support throughout the entire lifecycle.
Get tailored advice from a specialized team
Because products for different diseases will follow different paths to market, we offer deep expertise across many therapeutic and specialty areas, including oncology, rare diseases, cell and gene therapy, and others. Leveraging this specific knowledge, our consultants create tailored strategies for engaging patients, generating compelling evidence, developing value stories, and mitigating risk.
Our solution experts
Paul Bridges, Ph.D.
President, Consulting
Chris Learn, Ph.D., P.M.P.
Franchise Head, Cell and Gene Therapy and Early Phase
Lola A. Fashoyin-Aje, M.D., M.P.H.
Senior Vice President, Head of Regulatory Oncology, Cell & Gene
Mwango Kashoki, M.D., M.P.H.
Senior Vice President, Global Head of Regulatory Strategy
Stephen Pyke, DIC
Chief Clinical Data & Digital Officer
Mike D’Ambrosio
Senior Vice President and Global Head, Real World Research
Sanjay Vyas
President, Safety & Logistics and Country Head of India
Teri Karcher, Ph.D.
President, Global Project Leadership and Launch Excellence
Katie Connelly
Senior Vice President, Global Head of Regulatory Affairs
Our solution experts
Paul Bridges, Ph.D.
President, Consulting
Chris Learn, Ph.D., P.M.P.
Franchise Head, Cell and Gene Therapy and Early Phase
Lola A. Fashoyin-Aje, M.D., M.P.H.
Senior Vice President, Head of Regulatory Oncology, Cell & Gene
Mwango Kashoki, M.D., M.P.H.
Senior Vice President, Global Head of Regulatory Strategy
Stephen Pyke, DIC
Chief Clinical Data & Digital Officer
Services
Real-world evidence
Explore the impact of a therapy or disease in a real-world setting, generating data that can support your value proposition without additional burden to the patient. Our real-world evidence (RWE) strategies help reassure payers, regulators, providers, and patients that your clinical results are reflective of what will be evidenced in real-world practice, helping demonstrate value before, during, and after launch.
21%more likely drug launch with RWD
Our research with the Economist Intelligence revealed how real-world data (RWD) strategies like ours significantly improve the likelihood of a drug launching.
Global regulatory submissions and outsourcing
Navigate the dynamic landscape of regulatory requirements, including the ever-changing demands of dossier preparation, submissions, and lifecycle maintenance. Plan for the strategy and intelligence-gathering activities crucial to your success.
Let our global team of experienced regulatory professionals collaborate with your internal team, enabling them to remain agile, focused and dedicated to the strategic imperatives driving your innovation and corporate goals.
25,000+regulatory submissions each year
Our former FDA, EMA and NMPA regulators, supported by 1,300+ colleagues in local regulatory teams help you manage global complexity in changing regulatory environments.
Compliance and risk management
Building a culture of compliance while effectively managing risk is a delicate task that requires trusted expertise. Whether you’re in development or are manufacturing at commercial scale, we specialize in GxP compliance services.
The pandemic, and recovery from its impact pose unprecedented challenges to supply chain stability. Partner with Parexel to mitigate these risks, ensure regulatory compliance and secure the continuity of your supply chain.
100+GxP audits annually
Ensure uninterrupted supply, from development to manufacturing and market availability of vital products.
Market access strategy and delivery
The potential for new treatments to benefit patients becomes a reality in the later stages of clinical development. But success relies on satisfying the needs of key stakeholders. Neglecting the data required by regulatory agencies, payers, prescribers and health technology assessment (HTA) agencies can cause significant, and costly delays between approval and reimbursement.
We understand the intricacies of market access strategy and planning as you plan the pivotal trial. Work with our team to design the optimal path to meet the commercial requirements of your target markets.
600+global value dossiers in the last 10 years
We know how to build powerful global value dossiers that are elevated by clear, resonant value stories.
Medical communications
Engage the people who matter most. At Parexel, we combine a comprehensive portfolio of medical communications services with expertise in all major therapeutic areas, as well as clinical development, patient engagement, real-world evidence, health economics, market access, regulatory, and more — to communicate vital data to your stakeholders.
Our team consists of Medical Affairs strategists who collaborate with highly skilled PhD, PharmD, and MD writers, seasoned medical editors, meeting logistics experts, and creative, digital, and design specialists. Together, we enhance educational experiences and bring your science to life across every stage of development.
Our writers have deep experience across therapeutic areas, resulting in more relevant, impactful medical communications.
Drug safety & pharmacovigilance
In the rapidly evolving landscape of innovation-driven medicine, ensuring drug safety has become increasingly complex. With vast amounts of data from diverse sources, managing safety information is more challenging than ever. At Parexel, we leverage nearly 40 years of expertise to navigate these complexities, providing comprehensive pharmacovigilance services that prioritize patient safety throughout a product's lifecycle. Our integrated approach combines cutting-edge technology and AI-powered solutions to deliver actionable insights and streamline processes.
36+years of experience
With a global team of over 3,000 safety professionals, we support a wide range of therapeutic areas, ensuring regulatory compliance and unwavering commitment to patient health. Explore how our tailored solutions can help you meet the challenges of modern drug safety.
Integrated evidence generation planning
Parexel offers expertise in developing and delivering IEGP for various organizations, from big pharma to small biotech. Our services include early-stage strategy development, tactical planning, function-specific support, and advisory services.
By partnering with us for integrated evidence planning, you can maximize your assets' potential, streamline development processes, and improve commercial outcomes in a competitive market.
Operational excellence
Constantly evolving how we deliver trials
The purpose of our Operational Excellence and Delivery Office is to continuously and consistently improve the way we run your trials. By assembling our most experienced, cross-functional team members, we create best practices business wide that accelerate timelines, generate compelling evidence, promote innovation — and empower us to deliver With Heart™.
Frost & Sullivan's 2023 North American Customer Value Leadership Award
Parexel Recognized with Frost & Sullivan's 2023 North American Customer Value Leadership Award for impactful real-world evidence solutions addressing customer needs.
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