Regulatory Affairs Solutions

Our Solutions Clinical Development Phase II-IV Clinical Trial Management Regulatory Affairs Solutions

Accelerate outcomes with PPD Global Regulatory Affairs Solutions

Today’s regulatory environment is evolving rapidly, making faster approvals more challenging than ever. It’s critical to work with a partner that has global experience and expertise, intelligence-gathering strategies and the agility to shift in real-time.

With over 30 years of experience, the PPD clinical research business of Thermo Fisher Scientific has end-to-end regulatory solutions and a team of highly engaged, cross-functional regulatory experts to help you navigate the evolving global regulatory environment, accelerate outcomes and increase the probability of approval success.

Delivering the Right Expertise to Meet Your Regulatory Needs

It is critical for biopharmaceutical, biotech and medical device organizations to have the right support as they navigate regulatory approval and market access with comprehensive end-to-end regulatory services in both full-service outsourcing and functional service partnership (FSP) models.

Our comprehensive regulatory affairs solutions support the full product life cycle and all product groups, including small molecules, biologicals, biosimilars, vaccines, generics, advanced therapies, medical devices and diagnostics, and consumer and over-the-counter products.

Innovative intelligence systems proven to improve success

Up-to-date regulatory intelligence is fundamental to getting ahead and staying ahead in this highly volatile regulatory environment. With intelligence gathered from our successful regulatory submissions and our partnerships with regulatory bodies from around the world, we have developed state-of-the-art systems to facilitate extensive insight and experience sharing, ensuring our clients benefit from collective wisdom gained. This compilation of intelligence, insights and experiences improves the quality of decision-making, creates efficiencies, increases consistency, accuracy, and reliability, and improves the odds of submission success.

RegView:
Our proprietary intelligence platform, updated daily, provides actionable, timely regulatory intelligence from around the world and is validated with extensive personal experience.

Electronic common technical document (eCTD):
Our publishing solution expedites the delivery and validation of submissions by creating regulatory-compliant PDF files and validation tools to ensure quality published outputs satisfy technical requirements for health authority gateways and portals.
See Case Study

Regulatory Information Management System (RIMS):
Our RIMS tool optimizes operations by supporting timely and compliant management of end-to-end regulatory processes, including planning and tracking documents, submissions, registrations, commitments and more.

Regulatory Services Case Studies

Early regulatory success

Challenge:

Our client, a small sized U.S.-based biotechnology company developing gene therapy products, needed regulatory consultancy to enter the U.S. and European Union (EU) markets. Additionally, the client lacked in-house EU strategic and operational know-how and did not have a European Economic Area (EEA) established office to apply for and maintain EMA orphan designation.

Investigator Research IND was paper-based and not compliant with electronic common technical document (eCTD) requirements.

Solution:

We leveraged our extensive global regulatory experience to facilitate early engagement with U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) to receive feedback on clinical, marketing and post-marketing development plans.

Results:

We ensured compliance requirements were met by transferring ownership of IND from investigator to commercial IND and new sponsor within the first 90 days of being awarded the business.

We supported a variety of on-time and of-the-highest-quality submissions resulting in the client securing key product designations less than eight months post-award and achieving key business goals for the year.

Cartagena Type 1

Challenge:

Our client, a U.S. biotechnology company seeking to develop a gene-therapy project in Japan, did not have an established local office, including regulatory staff with gene therapy experience, to navigate the very complicated and evolving Japanese regulatory environment.

Solution:

Through our regulatory country-specific expertise in Japan, we delivered a robust strategy and successful PMDA consultation for the gene therapy product

Results:

Quality and on-time application of three Cartagena Type I Use resulted in approval by Ministry Health, Labour, and Welfare within six months of application.

Led the Cartagena Type I submission through successful chemistry, manufacturing and controls (CMC) and non-clinical consultation for the first project

Gained Pharmaceuticals and Medical Devices Agency (PMDA) acceptance of Japan to participate in the global trial without a Phase I trial in Japan.

Life Cycle Management Partnership

Challenge:

Our client, a long-term partner since 2013, entrusted us to support the applications for over 50,000 life cycle management submissions for 54 products in 165 countries

Solution:

Established comprehensive support, including a dedicated PPD Partnership Manager, regulatory submission leads, and PPD RA FLEX, and publishing resources committed to driving continuity and compliance while providing flexibility, quality and cost-predictability across the entire product portfolio.

As an integrated extension of the client’s RA function, we actively engaged in recommending process improvement/implementation, training and monitored established KPIs.

Established an effective executive governance to set vision and provide executive level oversight of strategic, operational and financial performance in accordance with the client’s goals.

Results:

The proof a successful partnership:

Significant cost savings as a result of low-cost hubs estimated at ~25%
Reduced time and cost per unit by up to 60% in first five years of partnership
Expertly managed task and scope expansions that ensured efficiency, flexibility and cost effectiveness
Unwavering quality of delivery guaranteed through effective monitoring and oversight

Publishing

Challenge:

A client with a rapidly growing portfolio was seeking compilation, publishing and submissions of EU/U.K. and ROW in eCTD and NeeS format.

Solution:

To ensure publishing support across different time zones and time regions, we utilized our 24/7 handoff model to deliver on relevant regional regulatory agency guidelines and requirements for electronic and PDF standards.

Provided dedicated support from an experienced core publishing team to oversee timeliness and quality of all publishing.

Results:

Increased productivity enabled by streamlining processes and strong, transparent client partnership.

Contact us

Ready to put regulatory success within reach? Let us help you navigate the complex regulatory environment. Schedule a meeting to see the difference we can make.

Regulatory Affairs Solutions

Accelerate outcomes with PPD Global Regulatory Affairs Solutions

Delivering the Right Expertise to Meet Your Regulatory Needs

Our regulatory affairs expertise, by the numbers

Innovative intelligence systems proven to improve success

Regulatory Services Case Studies

Early regulatory success

Cartagena Type 1

Life Cycle Management Partnership

Publishing

Contact us

Our regulatory affairs expertise,
by the numbers