Approval and access

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.

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I think it's really important to listen to the patients to understand what "clinical benefit" means to them. I'm really proud that Parexel is doing this. It's involving patients more and more in all of the interactions with the clients, with the studies, with strategies to help run studies more efficiently so that the patients want to enroll and stay

in studies throughout to the end.

Patients worldwide have seen us develop new therapeutic vaccines in record time and are asking the question, why can't we do that every time?

We should continue to evolve into faster pathways to development.

We at Parexel were involved in one of the first approvals that used real world evidence to support some of the decision making. And I think as we continue to think about innovative trial designs with our statisticians, innovative endpoints and biomarkers with our translational sciences, and innovative patient selection criteria, that we can move drug development to a faster pace.

There's no going back to the old ways of working these drug development programs and that I'm very excited by.

I expect we're going to be able to run our programs more quickly, more efficiently, and bring more assets to the market at prices that patients can afford and be reimbursed for. And that's very exciting.

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.

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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 1000+ colleagues in local regulatory teams help you manage global complexity in changing regulatory environments. 

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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.

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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.

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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.

Medical communications

Our writers have deep experience across therapeutic areas, resulting in more relevant, impactful medical communications.

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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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