Regulatory, Strategies & Submissions

Overcome the obstacles to get products to market faster and smarter

  • Plan & Engage Early To Manage the Risks of Risk Management

    Plan & Engage Early To Manage the Risks of Risk Management

    Read More
  • Where’s your heart? Tell us at the DIA Annual Conference in San Diego, June 24-26

    Learn More
  • Agency Readiness – Bob Iser2:48

    Agency Readiness – Bob Iser

    Watch Video
  • ×

    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!
  • Accelerated Pathways – Alberto Grignolo2:55

    Accelerated Pathways – Alberto Grignolo

    Watch Video
  • One step closer to a refined US Biosimilar Landscape

    One step closer to a refined US Biosimilar Landscape

    Navigating the commercial viability of the biologics market, in the context of a robust regulatory strategy to ensure a successful approval process for your biosimilar should not be tackled without th

    Learn More
  • Optimizing Clinical Trials To Support Marketing Approval Of Biosimilars

    Optimizing Clinical Trials To Support Marketing Approval Of Biosimilars

    Read More
  • ×

    Tell Us About Your Biotech Goals.

    What are your top priorities for 2019?
    Thank you!
    Error - something went wrong!
  • Tell us about Your Portal Experience!

    Email Us
  • 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
  • Nothing Costs More Than Failure

    Nothing Costs More Than Failure

    Learn the top reasons drugs fail to be recommended for market access.

    Read More
  • Bridging The Gap: Satisfying Payers In An Era of Expedited Regulatory Pathways

    Bridging The Gap: Satisfying Payers In An Era of Expedited Regulatory Pathways

    Ensure expedited regulatory approval effectively translates into reimbursement and patient access.

    Read More
  • Five Ways to Ensure Your Early Engagement with Payers and Regulators Pays Off

    Five Ways to Ensure Your Early Engagement with Payers and Regulators Pays Off

    Early Engagement is Smart but You Need to be Savvy when Engaging with Regulators and Payers.

    Read More
  • Strengthen Your Product Value Story One Phase at a Time

    Strengthen Your Product Value Story One Phase at a Time

    The best way to plan evidence generation for the value story is from the beginning.

    Read More
  • The Path to Better Trial Design

    The Path to Better Trial Design

    To strike a balance between rigor and cost-effectiveness, trials must be right-sized and the mistakes of the past avoided.

    Read More
  • Gaining Regulatory and Payer Approval:Five Benefits of Building a Robust Evidence Platform

    Gaining Regulatory and Payer Approval:Five Benefits of Building a Robust Evidence Platform

    Learn five benefits of building a robust evidence platform.

    Read More
  • A Smart Global Regulatory Submissions Strategy is Flexible, Nuanced and Nails the Logistics

    A Smart Global Regulatory Submissions Strategy is Flexible, Nuanced and Nails the Logistics

    Do you have the right plan in place? Learn three critical components for successful global regulatory submissions.

    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
  • Today's Gold Standard: Product Approval Demands Real-World Evidence

    Today's Gold Standard: Product Approval Demands Real-World Evidence

    Key strategies for providing real-world evidence to help ensure your product will reach its full potential.

    Read More
  • Early Economic Models Pay Off

    Early Economic Models Pay Off

    Early-stage economic models can improve reimbursement approval -- here are three examples.

    Read More
  • Safety Services: Supporting Emerging Companies with an End-to-End Solution

    Safety Services: Supporting Emerging Companies with an End-to-End Solution

    Highly efficient, compliant global pharmacovigilance processes to support organizations of all sizes.

    Read More
  • Accelerated Pathways: Global Opportunities and Challenges for Innovators

    Accelerated Pathways: Global Opportunities and Challenges for Innovators

    Navigate the opportunities and challenges accelerated pathways present with these key strategies.

    Read More
  • How to be Smart About Pre-IND and Other Meetings With the FDA

    How to be Smart About Pre-IND and Other Meetings With the FDA

    Read our strategies on how to be smart about pre-IND meetings and tips to reap the full benefits of meeting with the FDA.

    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
  • loading
    Loading More...