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Plan & Engage Early To Manage the Risks of Risk Management
Agency Readiness – Bob Iser
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
Optimizing Clinical Trials To Support Marketing Approval Of Biosimilars
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.
Nothing Costs More Than Failure
Learn the top reasons drugs fail to be recommended for market access.
Bridging The Gap: Satisfying Payers In An Era of Expedited Regulatory Pathways
Ensure expedited regulatory approval effectively translates into reimbursement and patient access.
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.
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.
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.
Gaining Regulatory and Payer Approval:Five Benefits of Building a Robust Evidence Platform
Learn five benefits of building a robust evidence platform.
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.
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.
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.
Early Economic Models Pay Off
Early-stage economic models can improve reimbursement approval -- here are three examples.
Safety Services: Supporting Emerging Companies with an End-to-End Solution
Highly efficient, compliant global pharmacovigilance processes to support organizations of all sizes.
Accelerated Pathways: Global Opportunities and Challenges for Innovators
Navigate the opportunities and challenges accelerated pathways present with these key strategies.
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.
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.
Regulatory Handbook: Data Integrity: FDA And Global Regulatory Guidance