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Regulatory Affairs Solutions

Accelerate outcomes with our 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.

Our regulatory affairs expertise, by the numbers

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30+ years of proven experience

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99% submission milestones achieved


Close to 400 regulatory staff across 40 countries

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More than 160 countries, including China, supported with comprehensive regulatory submission solutions

We believe your success requires a tailored approach. Because your regulatory and business needs are inextricably linked, we employ a scalable approach that brings in the right resources at the right time to advance your product down the right path. When you partner with us, your team will include a customized mix of individuals specifically selected because of their extensive, relevant clinical and commercial experience and in-depth knowledge of the regulatory landscape pertinent to your to driving regulatory success for your product.

We live in a global world filled with regional nuances. With experts throughout North America, Europe, the Middle East, Africa, Latin America and Asia Pacific—including one of the largest and most experienced regulatory teams in China – you gain timely insight and the highest quality consulting and strategic intelligence support to effectively navigate the ever-changing regulatory landscape while maximizing the probability of approval success and fair market access for your product along the way.

An unparalleled regulatory strategy and expertise and intelligence systems that help keep you ahead of change are key to success.

network of clinical trials sites
Early success Our knowledge and expertise with global regulatory groups put you on the right path from the beginning.
  • Provide strategy development, module and content development, SME review, application publishing, and maintenance submission
  • Support a variety of submissions (e.g., breakthrough therapy designation, orphan drug designation, regenerative medicine advanced therapy designation, priority medicines scheme, paediatric study plans/paediatric investigational plans)
  • Assist with regulatory authority meetings (i.e., meetings and ongoing interactions with the U.S. Food and Drug Administration, European Medicines Agency, Agencia Nacional de Vigilancia Sanitaria (ANVISA), Medicines and Healthcare products Regulatory Agency (MHRA and Health Canada)
See case studies
Submission success Submissions that are comprehensive and customized.
  • Develop submission strategy
  • Provide project planning, tracking and management
  • Prepare and manage source documents
  • Assemble, publish and validate submissions
Learn more
Life cycle success Maintenance for established products with an experienced team. We will provide strategy, execution and compliance to suit different needs, from a business and global regulatory perspective.
  • Flexibility, reliability and continuity working as an extension to a company’s own regulatory team, with capabilities to scale resources for peaks of activity
  • Experience and leadership to contribute to strategic plans, enabling market expansion
  • Tools and processes that drive efficient management of regulatory information and provision of metrics to assess agreed KPIs
  • Continuous improvement to identify new automations that reduce risk and eliminate errors
  • Trust-based partnership that applies aligned governance with clear roles and responsibilities to deliver over multiple years
See case study

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.

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


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 (European Medicines Agency) orphan designation.

Investigational New Drug (IND) research was paper-based and not compliant with electronic common technical document (eCTD) requirements.


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


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.


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.


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


Quality and on-time application of three Cartagena Type 1 Use resulted in approval by Ministry Health, Labour, and Welfare within six months of application.

Led the Cartagena Type 1 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.


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.


Established comprehensive support, including a dedicated 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.


The proof of 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


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


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.


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.