Group looking at a map

Regulatory Affairs

PPD has the Solution for Your Regulatory Challenge

Expertise, Intelligence, Strategy and Delivery

PPD has the unmatched scientific, regulatory and operational expertise you need, combined with global reach to help you achieve regulatory approval and market access for your product. Our strategic regulatory services span the full spectrum of activities and technical functions, including regulatory development, licensing and life-cycle management, regulatory strategy input and full-service regulatory partnerships. We deploy process improvement techniques and the latest technology, including PPD’s regulatory information management system (powered by Veeva Vault RIM), to ensure quality of delivery.

Due to the recent upheaval caused by the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulatory authorities have issued guidance providing some flexibility for clinical trials. However, there is no one-size-fits-all approach to applying such guidance. To ensure consistent compliance with regulatory updates, PPD continues to gather information from multiple agencies and update regulatory intelligence daily, both at a study level and on a country-by-country basis.

Your successful submission depends on up-to-date, relevant regulatory intelligence

You can access the experience gained from our successful preparation and management of regulatory submissions in over 160 countries. Our proprietary intelligence platform, PPD®RegView, enables us to utilize and share clear, comprehensive regulatory intelligence, overlaid and validated with our contemporary, extensive experience.

  • Legislation/regulations, processes and timelines
  • Industry practices
  • National/regional differences
  • Regulatory analysis
  • Regulatory precedence
  • Guidelines/directives
  • Opinions/advice
Ask the regulatory affairs team Our team of experts are ready to answer your questions. Contact Us
http://news
Explore regulatory insights Gain a better understanding through our blog articles. Read more
http://icon
Webinar: The Regulatory Maze Learn how regulatory guidance impacts digital solutions. Watch Now

PPD Provides Comprehensive Global Regulatory Expertise

Our industry-leading regulatory experts have extensive experience in global product development and global regulatory strategies across all phases and multiple pharmaceutical and medical device platforms. With regulatory staff in 38 countries, including well-established and expert teams in the U.S., Europe, China and Japan, we provide flexible, comprehensive consulting and delivery services including:

  • Clinical trial strategy and applications
  • Marketing authorization strategy and applications
  • Publishing and submissions management
  • Life-cycle management
  • Preclinical and CMC consulting
  • Agency interactions, including full management of formal agency meetings
  • Strategic consulting and intelligence
  • Expertise in wide range of therapeutic areas, CMC and nonclinical
  • Leadership in expert groups on hot topics such as advanced therapies, pediatrics and medical devices
  • Expertise in chemical drugs, biologicals/biosimilars, medical devices and drug/device combination products, generics and consumer products
  • Close working interface with other PPD functions, including medical writing and pharmacovigilance

GLOBAL REGULATORY
INTELLIGENCY AND INFORMATION

REGULATORY DEVELOPMENT EXPERTISE AND
GLOBAL STRATEGIES

NEW PRODUCT LICENSING
AND MARKET EXPANSION

MARKETED PRODUCT LIFECYCLE
MANAGEMENT AND COMPLIANCE

AD-HOC CLIENT SUPPORT
AND SPECIALIST CONSULTING

On the ground experts in all key markets

Our global reach provides local coverage in key countries, enabling us to apply up-to-date, robust regulatory intelligence to product development and registration strategies. We develop preemptive solutions for potential regulatory hurdles and ensure the quality of submissions to worldwide agencies to maximize the likelihood of successful review.

51 Offices Around the Globe
Offices with regulatory affairs presence, including clinical trial application (regulatory authority and ethics committee) submission handling.

Bulgaria India Mexico Philippines
PPD’s FLEX units provide functional outsourcing as a customizable solution that focuses on high quality, measurable outcomes and cost savings. This dedicated business unit focuses on a full range of regulatory services, including regulatory strategy and document preparation, publishing and lifecycle management.

OUR COUNTRY NETWORK ENSURES APPROPRIATE REGULATORY REPRESENTATION, RESPONSE AND ACTION TO SUPPORT PPD AND OUR CLIENTS THROUGHOUT THE WORLD.

USA

  • Deep experience in IND and NDA/BLA strategy and execution

  • Regular management of meeting and interfaces with U.S. FDA

  • U.S. agent services

Europe

  • Experience in management of new product approvals in centralized and national procedures

  • Ability to manage scientific advice and facilitate meetings with EMA or national authorities

  • Full clinical trial delivery with proactive planning for new EU clinical trial medical device and IVD regulation requirements

China

  • 300+ successful regulatory approvals or licenses since 2000

  • Full services covering regulatory consultation, IND/CTA/HGRAC/NDA, variation/renewal. chemicals/biologics, APIs, medical devices, IVDs, food and cosmetics.

  • Deep understanding of ongoing regulatory reforms in China and ability to practically navigate through these

Japan

  • Full management of CTN

  • Regularly performing role of in-country clinical caretaker

  • Full management of PMDA consultations