PPD Functional Service Partnership (FSP) Regulatory Affairs Solutions
Unparalleled support to guide market access and regulatory approval success
PPD™ FSP Regulatory Affairs solutions help biopharmaceutical, biotech and medical device organizations navigate regulatory approval and market access with comprehensive end-to-end regulatory services available in a functional service partnership (FSP) model.
Backed by over 30 years of experience, our solutions provide regulatory strategy, intelligence and delivery across the entire product life cycle – with the ease and convenience of a single global partner and much-needed resource flexibility, reliability and continuity.
Whether supporting a critical business task, a clinical trial, an entire portfolio or providing post-approval life cycle management, our cross-functional regulatory experts bring unmatched expertise and insights, a scalable approach and leading-edge systems. We help you navigate global regulatory environments, accelerate outcomes and increase the probability of approval success.
Outsourcing lifecycle maintenance to a dedicated FSP Regulatory Affairs partner
Regulatory expertise to increase your probability of approval success.
An unmatched level of expertise and commitment to quality
30+ years of regulatory services experience
Successful preparation and management of regulatory submissions in 160+ countries
Senior staff average 24 years of pharmaceutical and medical device experience and 18 years in regulatory affairs
400+ successful regulatory approvals or licenses In China since 2000
Proven track record of success
In the last five years, we’ve supported:
- 50+ new drug applications/marketing applications
- 140+ agency meetings
- Nearly 900 new market expansion licenses
- 5,950+ clinical trial applications/investigational new drugs
- 34,900+ lifecycle submissions
- 54,200+ clinical trial applications/investigational new drug updates
And we delivered:
- 99% first cycle approval
- Zero licenses lost or compromised
- Zero dossiers failing validation
- 99% submission milestones achieved
End-to-end regulatory solutions provide the ease of a single partner
PPD FSP Regulatory Affairs solutions provide strategic and technical services across the full product life cycle and all product groups:
Support for all clinical and peri- and post-marketing needs
Regulatory strategy & expertise: Develop global or regional regulatory strategies, identify relevant regulatory designations to expedite product review and approval, and support assets with unique challenges, such as rare diseases, cell and gene therapies, medical devices, biosimilars.
Regulatory intelligence: Monitor and assess the regulatory environment, review and benchmark competitor products, develop risk mitigation strategies, and create regulatory summary communications.
Regulatory science and innovation: Provide regulatory knowledge to accelerate innovation, improve decision making and influence future paradigms, like adaptive pathways, collaborative design, novel technological platforms and trial designs and advanced therapy solutions.
Market access strategies: Align regulatory and health technology assessment (HTA) guidance, design and implement market access strategies, drive strategies for early access and adaptive/conditional licensing with robust post-approval framework, and build evidence to achieve regulatory approval and support substantiated product value.
CMC, Non-clinical and clinical technical expertise: Author and provide scientific review of submissions, annual reports, drug master files (DMF), active substance master files (ASMF) and core registration dossiers, provide protocol assistance, and offer analytical and manufacturing process development consultation.
Investigational New Drug (IND) services: Provide strategy development, module and content development, SME review, and IND publishing and maintenance submission, assist with FDA meetings, and support a variety of submissions (e.g., breakthrough therapy designation, orphan drug designation, regenerative medicine advanced therapy designation, pediatric study plans).
Regulatory Publishing Solutions (RPS): Develop submission strategy, provide project planning, tracking, management, prepare and manage source documents, and assemble, publish, and validate submissions.
Labeling services: Develop clinical and peri- and post-approval content (development/company core data sheets (DCDS/CCDS), core/company core safety information (DCSI/CCSI), FDA target product profile (TPP), investigational product label/label mock-up), summary of product characteristics (SmPC), United States Prescribing Information (USPI), package information leaflet (PIL), review global advertising/promotional materials, and provide translation services.
Project management and oversight: Lead and oversee operational teams, merging project management capability with deep regulatory expertise, measure efficiency and quality using robust metrics and KPIs to drive improvements, adapt to changes in the field, manage cross-functional teams and identify, and coordinate consultations with subject matter experts, as needed.
Cross-functional experts increase the probability of success
Creating and executing a regulatory plan that increases the likelihood of product approval requires specialized, customized, cross-functional expertise. To meet your evolving needs and proactively anticipate and overcome challenges, our cross-functional teams include a customized mix of roles. We employ a mix of senior staff members with long-running regulatory experience in the pharmaceutical and medical device industries along with regulatory professionals and chemistry, manufacturing & controls (CMC) specialists.
Each team of decision makers is empowered with the flexibility to provide solutions that meet your unique needs. A typical team may include:
- A regulatory oversight director accountable for strategic management of the portfolio
- A regulatory affairs lead as the primary client contact, who is accountable for development and execution of strategies and submissions
- And multiple other roles, as needed, to fill out the team, including regulatory specialists, regulatory country managers, regulatory assistants, or clinical and commercial roles
By bridging regulatory affairs knowledge with extensive clinical and commercial expertise, our team develops strategies that enable the most efficient registration pathways to maximize the probability of regulatory approval and fair market access.
Global reach and specialized expertise helps accelerate your outcomes
With regulatory staff located throughout North America, Europe, Middle East, Africa, Latin America and Asia-Pacific – including one of the largest and most experienced regulatory teams in China – we deliver the specialized expertise needed to navigate local regulatory requirements, facilitate efficient reviews of applications and accelerate outcomes. We also leverage our regulatory FLEX Solutions Team (an adaptable resource pool in Mexico, India, the Philippines and Bulgaria) to effectively scale to manage changing needs.
In addition, we apply our extensive clinical and regulatory experience and expertise – and long-standing trusted relationships with national and regional regulatory authorities – to proactively monitor potential risks and challenges and anticipate and address queries raised.
Our global footprint and breadth of regulatory experience also gives us a clear view of the regulatory affairs future. By applying our local, regional and central regulatory intelligence, our active engagement and influence with industry and global health authorities, and regulatory thought leadership across a range of health authorities and stakeholders, we’re able to proactively address current challenges and influence future strategies across multiple geographies, product classes and regulatory agencies.
Proven systems provide the foundation for successful submissions
The regulatory landscape is dynamic and continually evolving, driven by local regulatory requirements, medical, scientific and technological advances, as well as industry and political influences. Amid rapid regulatory changes and anticipated significant changes to come, staying up to date with regulatory intelligence is key to a successful regulatory strategy.
To stay current on the latest regulatory updates, we continuously share intelligence gathered from our successful regulatory submissions at relevant meetings and forums worldwide. We also incorporate our intelligence and learnings into our systems to enable clients easy access to their data and submission archive and allow multiple parties to securely move seamlessly from one step to the next.
In addition, we apply our extensive clinical and regulatory experience and expertise – and long-standing trusted relationships with national and regional regulatory authorities – to proactively monitor potential risks and challenges and anticipate and address queries raised.
Our global footprint and breadth of regulatory experience also gives us a clear view of the regulatory affairs future. By applying our local, regional and central regulatory intelligence, our active engagement and influence with industry and global health authorities, and regulatory thought leadership across a range of health authorities and stakeholders, we’re able to proactively address current challenges and influence future strategies across multiple geographies, product classes and regulatory agencies.
Systems we leverage include:
- RegView: Provides proprietary, actionable regulatory intelligence from around the world through daily updates and is validated with extensive personal experience – including more than 13,000 summaries in over 150 countries for early development through post-approval and over 1,300 cross-country reports are updated daily.
- Publishing solution: Expedites the delivery and validation of submissions, via a “follow the sun” resourcing model, by creating regulatory compliant PDF files and validation tools to ensure quality published outputs satisfy technical requirements for health authority gateways and portals
- Veeva Vault Regulatory Information Management System (RIMS): Supports timely and compliant management of end-to-end regulatory processes, including planning and tracking documents, submissions, registrations, commitments and more
With these systems, we facilitate extensive intelligence and experience sharing. This improves the quality of decision making, creates efficiencies, increases consistency, accuracy, and reliability, and improves the odds of submission success.