Regulatory, Development and Commercial Expertise. Operational Excellence. One Source.

PAREXEL®

CONSULTING

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Navigating today’s development environment takes an experienced team you can trust

YOUR JOURNEY.OUR MISSION.®

The drug development and manufacturing journey has been disrupted. Globalization has extended supply and value chains, exposing developers to risks far beyond their control. The rise of patient power has added a new cohort of stakeholders to satisfy. Scientific advances have changed the ways clinical trials are designed and run. And finally, payers are scrutinizing drug costs and their benefits much more closely than ever before.

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ACCELERATE YOUR THERAPY’S JOURNEY WITH UNMATCHED REGULATORY AND COMMERCIAL EXPERTISE

For 35 years, PAREXEL Consulting has defined advisory excellence and innovation. Our ability to help you maintain control of your regulatory pathway is rooted in our unmatched expertise – and proven by the sheer number of projects we manage: over 100+ marketing applications and submissions and 15+ global development plans every year. PAREXEL’s 1000+ regulatory experts, including 50+ former regulators, cover 110 countries including the increasingly important Asia markets. Working together, we can help you plan earlier to extract greater value from your clinical trial data, and convert end-to-end clinical development, and commercial expertise into actions that speed the delivery of your therapy to the patients who need them.

GET GUIDANCE FROM MOLECULE TO MARKET

PAREXEL Consulting is your conduit to global accelerated drug development. We connect your journey with the expertise that gets you there – from Early Phase to In-Market. It’s all part of The Connected Journey™ of data-driven services, a first-of-its-kind, purpose-built ecosystem that combines PAREXEL’s human expertise, business processes, and cutting-edge technology and data to simplify and accelerate drug development.

Because knowledge can quickly become outdated in an environment like this, it’s more important than ever to work with professionals who are continuously updating their knowledge in complex product development and applying that knowledge to help both shape, and implement new regulations. That’s PAREXEL Consulting.

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PAREXEL CONSULTING SERVICES

Regulatory Affairs Support

• Global (HQ) Level

- Regulatory Strategy: Global product development strategy, Clinical, Non-clinical, CMC and Regulatory gap analysis, Due-diligence, Product and Indication prioritization, Regulatory pathway optimization and Acceleration strategy, Global labeling (CCDS updates), Marketing authorization applications (US, EU, China, Japan, Canada and Emerging Markets-ROW), Submis-sion planning (eCTD), Patient-focused development

- Health Authority Meetings: Preparation support, Briefing documents, Rehearsals, Meeting attendance and health authority liaison

- Quality systems inspection strategy and inspection readiness

- Strategic Compliance and Risk Management: Facility remediation and audits

- Submission Support: Storyboarding/Key messaging, Core submission preparation and authoring, Original application publishing with lifecycle maintenance, Lifecycle publishing, Global dossier management, RTQs, CTA core dossier development

- Stakeholder Management: Drug safety, Tech opps, Medical, Commercial, CMOs

- Mergers and Acquisitions: Planning, Submission authoring, Dossier collection and stakeholder management

• Local (Affiliate) Level

- Regulatory Strategy: Market-specific requirements/ regulatory intelligence, Local labeling/artwork, MAAs

- Submission Support: Variations, renewals, Annual reports, RTQs, Publishing, RIM support, Archiving, CTA submissions

- Stakeholder Management: Health agencies, GRA, Local safety, Local QA

- Regulatory writing/authoring to local affiliate level

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Regulatory Operations Support

• Investigational submission management

• Regulatory dossier compilation, publishing and dispatch

• Investigational submissions and lifecycle maintenance

• Market authorization submissions and lifecycle maintenance

• Post-approval lifecycle maintenance

• Report compilation and publishing and archiving

• Regulatory Information Management — data entry, data cleansing, data migration

• Content creation and document services

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RELIABLE GUIDANCE FROM THE MOST EXPERIENCED PROFESSIONALS

50+ Former regulators

from around the world

110 Countries covered

80+ Meetings with global

Regulatory Authorities (FDA, EMA, PMDA,

CFDA, etc.) per year

100+ Marketing applications and submissions (NDA, BLA, ANDA, MAA, JNDA,

501(k), etc.) per year

1,350+ Annual product reviews

and annual reports written and submitted

per year

1000+ Regulatory experts

15+ Global development

plans per year

REGULATORY STRATEGY & DEVELOPMENT PLANNING

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Maintain more control over your regulatory path and mitigate compliance risks with PAREXEL Consulting – especially when pursuing worldwide launches. Our experts provide an intimate knowledge of requirements in different markets and can help chart the optimal path for you. We provide practical interpretation and support implementa-tion of diverse regulatory guidance all around the world, including in new high-potential markets such as China.

Our Regulatory Consulting Services group is staffed by luminaries with 25 years of regulatory agency experience from the FDA, the EMA, and other regulators. Our experts have deep industry experience in drug development, and can offer insights into the competitive landscape, helping your teams interpret new and existing guidance every step of the way, anywhere in the world.

OPTIMIZE YOUR REGULATORY PATHWAY TO MAXIMIZE THE VALUE OF EVERY PRODUCT

Whether you need to establish the trust of regulatory agencies or regain it after an issue, our Strategic Risk and Compliance Management team is ready to help. They can guide you through remediation and data integrity audits and help shift compliance responsibilities from regulatory agencies to the manufacturer of the drug to give you first-mover advantages with proactive, built-in compliance. As manufacturing goes global, this becomes more important

for biopharmaceutical and medical device companies trying to protect their competitive advantage around the world.

Finally, our expert-led agency readiness services help assure that high-quality, timely dossiers are submitted, and cGMP-compliant facilities are used to ensure regulatory success.

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REGULATORY COMPLIANCEAvoid delays with expertise from former FDA, EMA and CFDA regulators

RESOLVE REGULATORY ISSUES WITH A GLOBAL COMPLIANCE TEAM

REGULATORY PARTNERSHIPS Control costs of mature programs without sacrificing readiness

PAREXEL Regulatory Operations Partnerships takes the effort, uncertainty and overhead out of managing mature products by matching the requirements of each drug in your portfolio to the skills of our team. Having an experi-enced regulatory operations team working on your behalf ensures maximum readiness and data integrity for any regulatory inspections. It also positions you to take advantage of regulatory reforms as they happen.

MAXIMIZE YOUR FLEXIBILITY AND MINIMIZE DISRUPTION

Whether it’s a few people to review and scrub data for consistency, a global network of experts schooled in emerging offshore regulatory concerns, or something in-between, our team is always ready to serve. PAREXEL only charges for the resources you need – and only when you need them. Should your needs change mid-stream, we will add, remove, or redeploy staff as required.

IMPROVE YOUR FORECASTING FOR GREATER EFFICIENCY

With PAREXEL, you’ll always get the latest thinking and technological advances on your projects with the attention of experts in on-going licensing support. But more than that, you can streamline business processes. Switching from a full-time employee model to a unit transactions model will help you better understand the true effort put into meeting regulatory needs. When coupled with PAREX-EL regulatory information management software that tracks regulatory effort over time, you will also be able to create more accurate forecasts, estimates and budgets – a huge win for any business.

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CLINICAL TRIAL REGULATORY SERVICES

PARTNER FOR GREATER FLEXIBILITY

PAREXEL Clinical Trial Regulatory Services offers a seamless global footprint. Whether you’re using the latest medical technology or submitting in ascending regions such as Asia, we have the experience to ensure the smoothest journey possible. Our innovative, centralized solutions have revolutionized the collection, management and sharing of data. And by coordinating multiple, simulta-neous submissions with PAREXEL Clinical Operations, we help you achieve fast trial start-up and follow-through. We also offer labeling services, either standalone or integrated into a full-service clinical trial management solution – from single labels to a full library, anywhere you need them.

We understand biopharmaceutical and medical device companies often work with multiple partners per study, so our processes and solutions are designed to work in multi-partite relationships. Whether you, PAREXEL or a third-party manages the clinical trial, PAREXEL Clinical Trial Application hubs offer maximum flexibility with fast, cost-effective submission solutions. All steps – from clinical trial submission plan, assembly, and application management through delivery, to the trial master archiving – reside in the hands of one dedicated team. No matter what you need from PAREXEL Clinical Trial Regulatory Services, that’s exactly what you’ll get.

Submit timely, cost-effective, compliant applications anywhere in the world

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LET OUR 35 YEARS OF EXPERIENCE AUGMENT YOURS TO ACCELERATE YOUR DRUG DEVELOPMENT JOURNEY

When you’re ready for a faster, smoother development journey, PAREXEL Consulting is ready to help you achieve it. Let our 50+ former regulators, 1,000+ regulatory experts and 35 years of in-market expertise augment your capabilities to help deliver your therapy to the patients who need them as quickly as possible.

For more information about PAREXEL® Consulting please contact regulatory.portal@PAREXEL.com

WHEREVER YOUR JOURNEY TAKES YOU, WE’RE CLOSE BY.

© 2018 PAREXEL International Corporation. All rights reserved.

CORPORATE HEADQUARTERS

195 West Street Waltham, MA 02451 USA +1 781 487 9900

Offices across Europe, Asia and the Americas

www.PAREXEL.com