PPD Inc Main Menu REGULATORY AFFAIRS PPD has the Solution for Your Regulatory Challenge Our Solutions Clinical Development Phase II-IV Clinical Trial Management Regulatory Affairs EXPERTISE, INTELLIGENCE, STRATEGY AND DELIVERY PPD has the unmatched scientific, regulatory and operational expertise you need, combined with global reach to help you achieve regulatory approval and market access for your product. Our strategic regulatory services span the full spectrum of activities and technical functions, including regulatory development, licensing and life-cycle management, regulatory strategy input and full-service regulatory partnerships. We deploy process improvement techniques and the latest technology, including PPD’s regulatory information management system (powered by Veeva Vault RIM), to ensure quality of delivery. Due to the recent upheaval caused by the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulatory authorities have issued guidance providing some flexibility for clinical trials. However, there is no one-size-fits-all approach to applying such guidance. To ensure consistent compliance with regulatory updates, PPD continues to gather information from multiple agencies and update regulatory intelligence daily, both at a study level and on a country-by-country basis. YOUR SUCCESSFUL SUBMISSION DEPENDS ON UP-TO-DATE, RELEVANT REGULATORY INTELLIGENCE You can access the experience gained from our successful preparation and management of regulatory submissions in over 160 countries. Our proprietary intelligence platform, PPD®RegView, enables us to utilize and share clear, comprehensive regulatory intelligence, overlaid and validated with our contemporary, extensive experience. Legislation/regulations, processes and timelines Industry practices National/regional differences Regulatory analysis Regulatory precedence Guidelines/directives Opinions/advice EXPLORE MORE REGULATORY INSIGHTS IN OUR BLOG NAVIGATE THE EU CLINICAL TRIAL REGULATION (EU CTR) PPD is well positioned to help you navigate the EU CTR 536/2014 requirements for your global product’s seamless lifecycle development. LEARN MORE ABOUT HOW PPD CAN HELP YOU NAVIGATE THE UPCOMING REGULATORY REQUIREMENTS Explore EU-CTR Navigate key insights about the EU Clinical Trial Regulation 536/2014. READ MORE Webinar: The Regulatory Maze Learn how regulatory guidance impacts digital solutions. WATCH NOW Ask the regulatory affairs team Our team of experts are ready to answer your questions. CONTACT US PPD PROVIDES COMPREHENSIVE GLOBAL REGULATORY EXPERTISE Our industry-leading regulatory experts have extensive experience in global product development and global regulatory strategies across all phases and multiple pharmaceutical and medical device platforms. With regulatory staff in 38 countries, including well-established and expert teams in the U.S., Europe, China and Japan, we provide flexible, comprehensive consulting and delivery services including: Clinical trial strategy and applications Marketing authorization strategy and applications Publishing and submissions management Life-cycle management Preclinical and CMC consulting Agency interactions, including full management of formal agency meetings Strategic consulting and intelligence Expertise in wide range of therapeutic areas, CMC and nonclinical Leadership in expert groups on hot topics such as advanced therapies, pediatrics and medical devices Expertise in chemical drugs, biologicals/biosimilars, medical devices and drug/device combination products, generics and consumer products Close working interface with other PPD functions, including medical writing and pharmacovigilance GLOBAL REGULATORY INTELLIGENCY AND INFORMATION REGULATORY DEVELOPMENT EXPERTISE AND GLOBAL STRATEGIES NEW PRODUCT LICENSING AND MARKET EXPANSION MARKETED PRODUCT LIFECYCLE MANAGEMENT AND COMPLIANCE AD-HOC CLIENT SUPPORT AND SPECIALIST CONSULTING ON THE GROUND EXPERTS IN ALL KEY MARKETS Our global reach provides local coverage in key countries, enabling us to apply up-to-date, robust regulatory intelligence to product development and registration strategies. We develop preemptive solutions for potential regulatory hurdles and ensure the quality of submissions to worldwide agencies to maximize the likelihood of successful review. 51 Offices Around the Globe Offices with regulatory affairs presence, including clinical trial application (regulatory authority and ethics committee) submission handling. Bulgaria India Mexico Philippines PPD’s FLEX units provide functional outsourcing as a customizable solution that focuses on high quality, measurable outcomes and cost savings. This dedicated business unit focuses on a full range of regulatory services, including regulatory strategy and document preparation, publishing and lifecycle management. OUR COUNTRY NETWORK ENSURES APPROPRIATE REGULATORY REPRESENTATION, RESPONSE AND ACTION TO SUPPORT PPD AND OUR CLIENTS THROUGHOUT THE WORLD. USA EUROPE CHINA JAPAN Legal Notices Site Map Modern Slavery Transparency Statement Privacy Policy ©2021 PPD Inc. All Rights Reserved. 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