Integrated Expertise for a More Efficient, Effective Journey
Companies developing complex medical devices and in vitro diagnostics today are under stricter regulation and greater financial pressures than ever. Investors, regulators and third party payers all expect results fast, and proof of efficacy and product quality even faster. This is why you need a partner with PAREXEL’s fully integrated global resources and medical device experience to guide you.
At PAREXEL, the expertise you need begins with our regulatory consultants, many of whom are former senior regulators themselves. They have the insights to help you advance your device development effort from Proof of Concept to commercialization. Our goal is to provide our clients with the advice they need to maintain their competitive edge in a challenging business and regulatory environment. PAREXEL consultants have considerable experience preparing regulatory strategies, managing pre-submission meetings with FDA and other regulatory bodies worldwide. We also work with our clients to prepare Investigational Device Exemptions, 510(k) Premarket Notifications and Premarket Approval applications. Our medical device experts also draw upon all the global resources at PAREXEL including pre-clinical testing strategy, clinical trial design, human factors evaluation and reimbursement experts.
PAREXEL compliance experts will work with you to implement and maintain an effective Quality System, including Design Controls in order to meet FDA, EU and ISO 13485 requirements for approvals and/or CE marking qualification. PAREXEL compliance experts work with medical device companies at all stages of development to help them address quality issues identified internally as well as those identified by regulators.
Combination Products including medical devices and pharmaceuticals are increasingly common. PAREXEL is uniquely positioned to provide combination product developers with coordinated advice from both medical device and pharmaceutical experts. Our team approach provides developers of combination products such as drug delivery devices and companion diagnostics with strategies for success.
Given the time pressures and costs to develop complex medical devices, you want yours to be marketable worldwide. PAREXEL’s global resources provide you with regulatory details at every stage, localized clinical testing resources to contain your costs and build data for your applications, and tools to commercialize your device effectively once it is approved.