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
NAVIGATE THE EU CLINICAL TRIAL REGULATION (EU CTR)
PPD is well positioned to help you navigate the EU CTR 536/2014 requirements for your global product’s seamless lifecycle development.
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
- Deep experience in IND and NDA/BLA strategy and execution
- Regular management of meeting and interfaces with U.S. FDA
- U.S. agent services
- 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
- 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
- Full management of CTN
- Regularly performing role of in-country clinical caretaker
- Full management of PMDA consultations