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© 2000-2020. Parexel International Corporation.
Phase IIIb-IV
Clearing the market access hurdle.
Late phase is an exciting stage of your clinical development as it transitions from testing to commercialization. Marketing authorization is in progress , and we’re ready to help you connect the dots and sustain momentum. Stakeholders including regulators, payers, physicians, and patients all need to be satisfied that your drug or device is safe, effective, and offers greater value or benefit than current standard of care. Parexel’s Regulatory & Access consulting organization – an elite team of 1000+ consultants help clients chart the best, most-efficient, course through global regulatory, market access and commercial hurdles.
We’ve integrated regulatory and market access expertise to provide a source of disruptive innovation for clients looking for competitive advantage across every step of their development programs. Our Regulatory & Access consulting organization includes ~100 former regulators and HTA assessors to share innovative thinking, and practical, actionable insights. Because they wrote the guidance yesterday, our consultants know exactly how to interpret it today to give you a strategic advantage.
Parexel’s Real-World Evidence (RWE) experts help companies explore the impact of a therapy and/or disease in a real-world setting and generate real-world data that can support your proposition to regulators, payers, physicians and patients. We understand the need for interconnected, patient-specific that's longitudinal in order to track outcomes over time, and we are helping many companies solve this challenge including with the use of hybrid prospective/retrospective RWE studies.
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NMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020
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Will the FDA “CARE” More About Your Supply Chain?
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GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”
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The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19
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What’s Around the Corner for FDA Inspections?
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SEE FULL CONTENT STREAM
NMPA Guidance on the Management of Clinical Trials during the COVID-19 from July 2020
Read Now
Will the FDA “CARE” More About Your Supply Chain?
Read Now
GxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”
Read Now
The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19
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What’s Around the Corner for FDA Inspections?
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Has EMA started a domino effect for more regulation of API manufacturing?
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Regulatory & Access: Local knowledge
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Making a Seamless Transition to Virtual Meetings with Health Authorities: Best Practices and Recommendations
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5 strategies for mitigating the impact of COVID-19 on clinical trials
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EMA Guidance: Management of Clinical Trials - What it means for Patients?
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FDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with COVID-19
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Using risk assessment decision tree models to maintain safety and data validity in clinical trials during COVID-19
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Putting the Pandemic in Plain Language
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Navigating new steps in how FDA is managing COVID-19 Products
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Understanding the COVID-19 regulatory procedures the FDA is using
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How COVID-19 is Accelerating Telemedicine Adoption in Asia Pacific
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Rare Diseases: Aligning Expertise
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The Changing Fortunes of Telemedicine in Europe – Past, Present, and Future beyond COVID-19
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COVID-19 Vaccine Development - Part 2: Non-clinical and Early phase clinical development
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COVID-19 Vaccine Development - Part 3: Late stage clinical development and field trials
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Part Two: The Unique Impact of COVID-19 and Implications for the MSK Industry
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The Great Lockdown of 2020: Will the Life Sciences Emerge Unscathed?
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Rapid Responders: How Innovative Technologies are Accelerating Development of New Vaccines
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Perspective on Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency
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Back to the future – Are you prepared to meet unprecedented demand to use old drugs for new purposes?
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Solutions for sustainable supply chains in a period of global tumult
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COVID-19 isn’t putting FDA out of the compliance business – Be ready for inspection alternatives
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Restricted pharmaceutical exports from India: Are you ready to mitigate risk of drug shortages?
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CAR-T: How far have we come and where are we going?
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Rescuing Product Approvals from Data Integrity Issues
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Reflections on Cancer Drug Development Strategies with Newly-Introduced Chinese Regulations
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How the UK's HTA Agency Uses Real-World Evidence to Develop Guidance
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Episode 4: Accelerated Regulatory Pathways and Patient Access
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It’s Not Just Manufacturing – Drug Development Presents Corporate Compliance Risks Too
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FDA Inspections and Cleaning
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Can FDA Really Do That? Understanding FDA’s Jurisdiction
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Rare Disease and Orphan Drug Designations - What You Need to Know
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Does FDA Consistently Assess Product Quality Risk and Control in Applications?
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Critical Differences Between a Form FDA 483 and Warning Letters
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Press announcement: Parexel unveils combined Regulatory & Access consulting organization
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Reimagining The Global Value Dossier - Part 6
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Don’t Shortchange Your Due Diligence When It Involves Applications – FDA Won’t
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How to align your market access activities with your product value strategy
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Biosimilars in China: Riding an upward trend
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Reimagining the Global Value Dossier - Part 4
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Capturing the patient voice in market access communications
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