Regulatory, Strategies & Submissions

Overcome the obstacles to get products to market faster and smarter.

  • Parexel Regulatory & Access Overview Brochure

    Parexel Regulatory & Access Overview Brochure

    Read 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
  • ×

    Speak to a Parexel® Biotech expert today!

    First Name
    Last Name
    Job Title
    Company Name
    Country
    Tell us how we can help
    Thank you!
    Error - something went wrong!
  • RWE in an evolving regulatory landscape: Using real-world evidence to support novel product development pathways

    RWE in an evolving regulatory landscape: Using real-world evidence to support novel product development pathways

    In this on-demand webinar, Parexel experts discuss the growing interest in RWE from both regulators and payors and the advantages of using real-world data (RWD) to streamline the research process.

    Learn More
  • Cell and Gene Therapy & Tissue Engineering

    Cell and Gene Therapy & Tissue Engineering

    Read More
  • Agency Readiness – Bob Iser2:48

    Agency Readiness – Bob Iser

    Watch Video
  • Tell Us About Your Content Hub Experience!

    Email Us
  • ×

    Tell Us About Your Biotech Goals.

    What are your top priorities for 2020?
    Thank you!
    Error - something went wrong!
  • Accelerated Pathways – Alberto Grignolo2:55

    Accelerated Pathways – Alberto Grignolo

    Watch Video
  • Strategies for Working with Global Regulatory Agencies

    Strategies for Working with Global Regulatory Agencies

    Early engagement with regulatory authorities can help boost regulatory success rates and also help shorten clinical development timelines.

    Read More
  • Liquent InSight®: The Right Choice for Regulatory Information Management

    Liquent InSight®: The Right Choice for Regulatory Information Management

    Read why 18 of the top 20 pharmaceutical companies are using a module of the Liquent InSight® platform as their single, authoritative source for regulatory information.

    Read More
  • Phase III Trial Failures: Costly But Preventable

    Phase III Trial Failures: Costly But Preventable

    This article examines reasons for the high failure rate of Phase III studies and innovative approaches companies can take to mitigate risk.

    Read More
  • Three Steps for Filling Real-World Evidence Gaps

    Three Steps for Filling Real-World Evidence Gaps

    Create a strong RWE evidence strategy that addresses three critical factors: product differentiation, clinical outcomes in the real world and evidence gaps that may crop up suddenly.

    Read More
  • loading
    Loading More...