Integrated Product Development
Supporting the prioritization of assets and portfolios, including determination of the most optimal regulatory and clinical development paths.
Your Strategic Guide on the Product Development Journey.
As pressure builds on available healthcare resources globally, regulators are applying higher levels of scrutiny and manufacturers are looking ever more critically at a drug development process largely conceived in an era of blockbusters.
While innovation is being applied to solve the challenges of science and technology, successfully achieving regulatory approval and reimbursement demands even more - a REINVENTION of the development process, with new vitality applied to the integration of clinical and regulatory strategies that drive commercial success.
As a result, companies are examining every aspect of their development processes: How can they optimize their portfolio for commercial success? How can they make more informed go/no-go decisions? How can they effectively leverage rapid approval programs? Developers need to know how to navigate regulatory regimes across the globe, how to make smarter advancement decisions, and how to integrate powerful new outsourcing solutions into their operational strategies.
PAREXEL Consulting overcomes the obstacles to get products to market faster and smarter. Our scientific, regulatory, and operational expertise puts best practice standards to work for clients large and small, designing solutions for a constantly evolving healthcare landscape.
Key Offerings
Key Materials
Key Offerings
Key Materials
Key Offerings
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Strategic Compliance & Risk Management
Instituting proactive compliance and risk management with a strong track record in regulatory crises management.
Regulatory Outsourcing
Delivering a high quality, cost effective solution for lifecycle maintenance of established products.
Regulatory Information Management & IDMP Solutions
Ensuring compliance with a focus on efficiency, inclusive of data submissions using the Identification of Medicinal Products (IDMP) ISO Standards.
Key Materials
FDA Week, Vol. 19, No. 18, May 3, 2013
Interview with Mark Mathieu, PAREXEL Consulting
The RPM Report, March 2013
George Mills, David Chesney, Ravi Haranpanhalli, David Morse, Sally Choe, Mark Mathieu
Synchronizing regulatory, clinical and commercial strategies during product development to address the needs of regulators, payers, providers and patients.
An overview of the biosimilar concept, focused on the European Union's approval process for "similar biological medicinal products."
Emerging FDA review outcome trends for new drugs.
Learn how PAREXEL delivered more than 700 narratives within just over 11 weeks, as a standalone service to support the pivotal CSR written in-house at the sponsor.
Learn how the Testim™ brand team leveraged our integrated eMarketing approach to develop and manage an online marketing campaign designed to create awareness and stimulate demand for the product.
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