Regulatory submissions & planning

  • Patient engagement: Being heard3:04

    Patient engagement: Being heard

    Parexel’s Leslie DeVos and Katie Connelly both VP’s of Regulatory & Access have a heartfelt conversation with Lennie & Denny Woods, Parents & Co-Founders of Sara’s Cure (https://sarascure.org/), of th

    Watch Video
  • ×

    Register now for full access to all the content

    First Name
    Last Name
    Company Name
    Title
    Country
    Thank you for registering!
    Error - something went wrong!
  • Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

    Drug Development for Rare Disease and Oncology During the COVID-19 Pandemic

    Learn More
  • Parexel on the Pulse1:49

    Parexel on the Pulse

    Watch Video
  • How to interact virtually with health authorities

    How to interact virtually with health authorities

    View Now
  • The Special Approval Pathway (SAP) for COVID-19 related products in China

    The Special Approval Pathway (SAP) for COVID-19 related products in China

    The regulatory pathway for COVID-19 drugs in China is governed by the Special Approval Program (SAP) which was introduced by National Medical Product Administration (NMPA) in 2005.  SAP is...

    Learn More
  • ×

    Speak to one of our experts today

    First Name
    Last Name
    Company Name
    Title
    Country
    Tell us how we can help
    We'll be in touch shortly!
    Error - something went wrong!
  • Top 10 Myths About Working with the FDA for an Oncology Drug Approval

    Top 10 Myths About Working with the FDA for an Oncology Drug Approval

    Among biotech companies, a primary concern is how to establish a clinical strategy for scientific and commercial success at the earliest stage. In that respect, regulatory considerations figure...

    Learn More
  • The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19

    The New Pragmatism: Clinical Trials, Investment and Regulations Post-COVID-19

    Once the COVID-19 pandemic passes or is contained, the world will look and work very differently. The biopharmaceutical industry is no exception. In this podcast, Peyton Howell, Parexel’s Chief...

    Learn More
  • Making a Seamless Transition to Virtual Meetings with Health Authorities: Best Practices and Recommendations

    Making a Seamless Transition to Virtual Meetings with Health Authorities: Best Practices and Recommendations

    Chances are, you are reading this article in your home office, or perhaps in a corner of the dining room – but probably not in your normal workspace. Just as most of us have had to adjust to...

    Learn More
  • CAR-T: How far have we come and where are we going?

    CAR-T: How far have we come and where are we going?

    In this episode, Doug Olson, one of the first CAR-T patients treated on a clinical trial for CLL almost 10 years ago, details his experiences with this therapy in its earliest days....

    Learn More
  • Reflections on Cancer Drug Development Strategies with Newly-Introduced Chinese Regulations

    Reflections on Cancer Drug Development Strategies with Newly-Introduced Chinese Regulations

    The global cancer drug market is set to maintain strong growth over the next decade due to factors such as environmental pollution, population aging, and poor lifestyles that leave...

    Learn More
  • Rare Diseases: Aligning Expertise2:06

    Rare Diseases: Aligning Expertise

    See how Parexel are bringing together regulatory and market access experts to help companies developing rare and orphan disease products. Learn more about our Regulatory & Access Consulting Group: htt

    Watch Video
  • Parexel Regulatory & Access Overview Brochure

    Parexel Regulatory & Access Overview Brochure

    View Now
  • NDA to BLA Transition Products, FDA List Grew Recently

    NDA to BLA Transition Products, FDA List Grew Recently

    FDA has reviewed and approved the majority of therapeutic biological products (i.e. Biotechnology Products) under the Public Health Service (PHS) Act.  Most are submitted as BLAs and most...

    Learn More
  • Rare Disease and Orphan Drug Designations - What You Need to Know

    Rare Disease and Orphan Drug Designations - What You Need to Know

    Collectively, rare diseases affect over 30 million Americans.  The Orphan Drug Act (ODA), which provides the statutory basis for FDA to designate a drug or biologic agent as a therapy for a...

    Learn More
  • Commercial and Regulatory Strategy Considerations for Biotech

    Commercial and Regulatory Strategy Considerations for Biotech

    Many critical and innovative new therapies today, including those for rare and untreated diseases, are in the biotech pipeline. In fact, today biotech represents more than 80 percent of the...

    Learn More
  • A Long and Winding Road for Transdermal Products – FDA Has It Covered

    A Long and Winding Road for Transdermal Products – FDA Has It Covered

    On November 22, 2019 the Food and Drug Administration (FDA) published a Level 1 draft guidance titled Transdermal and Topical Delivery Systems - Product Development and Quality...

    Learn More
  • Biosimilars in China: Riding an upward trend

    Biosimilars in China: Riding an upward trend

    In February 2019, National Drug Regulators in China approved the country’s first ever biosimilar product referencing Rituxan, a monoclonal antibody[1].  This biosimilar product, HLX01...

    Learn More
  • Parexel Biotech: The value of patient-centric approaches - escaping the clinic4:24

    Parexel Biotech: The value of patient-centric approaches - escaping the clinic

    Parexel’s Rosamund Round, Director, Patient Innovation Center and Amy McKee, Vice President, Regulatory Consulting Services sit down with Monica Theis, a breast cancer survivor and two-time clinical t

    Watch Video
  • New Post-Market Surveillance Requirements (PMS) for all Medical Device Manufacturers

    New Post-Market Surveillance Requirements (PMS) for all Medical Device Manufacturers

    With a three (3) year transition period, the European Medical Device Regulation (MDR) replaces the current Medical Device Directives from May 26, 2020 on. Article 120, however, allows legal...

    Learn More
  • Regulatory Update: Patient Engagement in Drug Development

    Regulatory Update: Patient Engagement in Drug Development

    This month, the FDA released a draft of its second patient-focused drug development (PFDD) guidance document, detailing best practices for understanding patient experiences and the related...

    Learn More
  • loading
    Loading More...