PRA’s Global Regulatory Affairs (GRA) group brings more than 20 years’ experience navigating the complex regulatory environment. We leverage our experience to allow our clients to focus more time on bringing their lifesaving products to market.
PRA has the regulatory capability, knowledge, and experience to efficiently manage products worldwide throughout their complete regulatory life cycle. Our internal GRA department is comparably structured to pharma and biotech regulatory organizations, which means we build our project teams to meet your needs while not duplicating efforts. Our team provides country-specific and local regulatory expertise and acts as client representatives for submissions, including direct communications with regulatory authorities and key stakeholders.
PRA distinguishes itself in the industry through our GRA organization which comprises the following specialty functions:
- Regulatory Strategy and Agency Liaison provides global regulatory consulting and strategic guidance for products throughout the development life cycle, including registration and post-marketing support for marketing authorizations in nearly 100 markets worldwide.
- Regulatory Operations acts as a full-service regulatory partner with industry-leading expertise in all areas of regulatory operations. The group operates through 2 distinct and harmonized functions:
- Regulatory Project Management & Submission Operations provides mature regulatory project and submission management services with demonstrated success in facilitating the planning and implementation of regulatory projects such as acquisitions and divestments as well as global filing dossiers. Supporting the submission delivery team is a group of experienced publishers who are well versed in the provision of compliant electronic Common Technical Document (eCTD) and non-eCTD global submissions.
- Regulatory Technology & Information Management has direct experience with implementing, maintaining, supporting, and working in PRA- and client-owned regulatory systems. Our Regulatory Information Management team provides clients with centralized data entry and information governance services. Our Regulatory Document Management team has extensive experience providing a range of services, including day-to-day submission document archiving, document migration initiatives, and driving the data transfer elements of divestment and acquisition projects.
- Regulatory Labeling specializes in labeling content development, project management, labeling document review, and compliance throughout the product life cycle. Our experienced team of labeling resources are available for day-to-day labeling activities or to provide consulting and process improvement support.
- Regulatory Chemistry, Manufacturing, and Controls (CMC) provides sound regulatory strategies across development, registration, and post-marketing approval to ensure CMC practices are compliant with the requirements of global regulatory agencies. These strategies are executed by industry-leading experts with comprehensive knowledge in all areas of regulatory CMC.
- Medical Writing and Quality & Editing provides highly experienced in-house medical writing support and quality control and editing services. Our professionals have both industry and CRO experience in all phases of clinical development and in all major clinical indications.
- Clinical Trial Transparency offers complete trial disclosure life cycle management, with industry-leading expertise in global trial disclosure requirements, redaction, and Plain Language Summary writing.
We are global leaders who strategically shorten approval timelines and efficiently get your products to market and beyond.
We continuously monitor today’s complex and ever-changing global regulatory landscape to efficiently deliver quality regulatory services and submissions. Our global experts bring a deep understanding of local regulatory requirements to every project, keeping your research on time and on budget. We develop project plans that anticipate the requirements for product approval and mitigate risks or challenges that may arise. By staying ahead of all current legislation, guidelines, and other regulatory intelligence, we can advise you across all aspects of the development process, including maintenance of marketed products.
Lessons Learned From Preparing and Submitting an IND Application for a COVID-19 Treatment Candidate
Associate Director of Regulatory Project and Submission Management, Efi Sergi, delves into PRA’s experience creating an investigational new drug…
Clinical Trial Disclosure - Requirements & Strategy Considerations within Clinical Trial Transparency
Clinical Trial Disclosure (CTD) is a compliance requirement mandated by various national laws and policies, and is at the heart of a paradigm shift…
Plain Language Summaries - Keeping the End in Mind: Key Considerations for Creating Plain Language Summaries
Plain language summaries (PLS), also known as lay summaries and trial results summaries, educate participants and the public about clinical trial…
Data Sharing & Anonymization - Current Overview of Data Sharing within Clinical Trial Transparency
Clinical trial transparency has emerged in recent years as a key function within pharmaceutical and academic organizations. Although trial…
New Agency Liaison Opportunity in the EU
Scientific advice is a regulatory process expected to, “facilitate timely access to safe and efficacious medicinal products to patients and users of…
We are committed to keeping our clients abreast of changes in the regulatory landscape to ensure patients are protected and your goals stay on track.
PRA has the regulatory capability, knowledge, and experience to efficiently manage products worldwide throughout their complete regulatory life cycle. Our internal GRA department is comparably structured to pharma and biotech regulatory organizations, which means we build our project teams to meet your needs while not duplicating efforts. Our team provides country-specific and local regulatory expertise and acts as client representatives for submissions, including direct communications with regulatory authorities and key stakeholders.Discover how our Pharmacovigilance and Patient Safety solutions help us better protect patients
We employ a flexible service model, comprising cross-functional team members that provide full regulatory, scientific, and medical writing support across the entire product life cycle. Our combined industry and CRO experience, in all phases of clinical development and commercialization and in all major clinical indications, allows us to provide expert regulatory project management and consultancy services to meet your complex and evolving needs.
PRA also has a Global Regulatory Clinical Services team, performing clinical trial maintenance activities, clinical trial applications, and other clinical regulatory services. Please contact us to learn more about the full scope of our regulatory capabilities.
Basics of Regulatory Strategy
Driving development of drug products from pre-IND through marketing.
Pediatric Product Development Plan
Development of the Pediatric Study Plan (PSP) for the United States Food and Drug Administration and the Pediatric Investigation Plan (PIP) for the…
Regulatory Operations: An Evolution Aligned with Changing Industry Needs
One of the most persistent challenges for companies when it comes to regulatory operations is balancing the right level of support with the right…