Regulatory submissions & planning

  • 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
  • ×

    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!
  • 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
  • ×

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    On November 22, 2019 the Food and Drug Administration (FDA) published a Level 1 draft guidance titled Transdermal and Topical Delivery Systems - Product Development and Quality...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

    Strategies for Working with GRAs

    View Now
  • Case study condensed submissions

    Case study condensed submissions

    View Now
  • Case Study Global Regulatory Lifecycle Management

    Case Study Global Regulatory Lifecycle Management

    View Now
  • Regulatory Services Overview Infographic

    Regulatory Services Overview Infographic

    View Now
  • Brexit - the story so far

    Brexit - the story so far

    View Now
  • Using real-world evidence to help your product succeed

    Using real-world evidence to help your product succeed

    View Now
  • Regulatory Consulting Brochure

    Regulatory Consulting Brochure

    View Now
  • 3 Ways to Reap Benefits_Adaptive Trials

    3 Ways to Reap Benefits_Adaptive Trials

    View Now
  • Navigating Global Regulatory Submissions3:00

    Navigating Global Regulatory Submissions

    Watch Video
  • Accelerated Pathways – Alberto Grignolo2:55

    Accelerated Pathways – Alberto Grignolo

    Watch Video
  • loading
    Loading More...