Whatever your stage of clinical development, you need a CRO partner that can provide the global regulatory capabilities to support your product or device. Read on to learn more about how we can assist with global product regulatory activities, throughout the development life cycle, to accelerate drug approval.
A Precisely Developed Clinical Regulatory Strategy Lays the Foundation of Your Development Pathway, Adding Value Throughout Your Product Lifecycle.
Our Specialized Areas of Expertise in Global Regulatory Consulting
- Strategic regulatory advice for effective development of products
- For all phases of product development, global agency meetings with regulatory bodies such as the EMA, FDA, NMPA and PMDA
- Expedited programs, including Fast Track, Breakthrough therapy, Sakigake Designation and PRIME (PRIority Medicines)
- Regulatory experts in developing approval strategies in the multifaceted US 505(b)(2) drug development environment and similar programs worldwide
- Specific expertise in biosimilar product development, including complete elaboration of a tiered approach – a complete stepwise head-to-head comparison at the levels of quality, safety and efficacy to demonstrate comparability of the biosimilar and the reference product, including a complete analytical similarity assessment, an evaluation of the non-clinical testing and design of the clinical program
- Full electronic publishing capabilities, including eCTD conversion of paper and hybrid applications to complete compilation and publishing of eCTD submissions
- Post-filing support to provide complete response to regulatory inquiries
Our Regulatory Content and Submission Management Services:
Compiling, Publishing and Submitting eCTD Dossiers
- Compiling and publishing eCTD submissions
- Using a validated eCTD submission tool to compile and publish the eCTD submissions
- Creating hyperlinks between the various CTD sections for ease of navigation and review
- Submitting eCTD applications via the Electronic Submissions Gateway (ESG)
- Submission Ready Component Services
- Formatting of Microsoft® Word and Adobe® PDF documents to comply with the FDA’s PDF specifications
- Content and Submission Management
- eCTD Content Plan creation and management for original applications
Delivering Value and Leadership in Clinical Regulatory Consulting
- A single solution point for all your clinical development and commercialization needs
- Regulatory strategy and consulting integrated within our CRO and Commercial Contract Organization (CCO)
- A team of regulatory experts
- An experienced regulatory team including industry experts and regulatory writers, many with 25+ years of regulatory and drug/device development experience
- Experts in non-clinical and CMC requirements
- Experienced in global orphan drug and pediatric requirements
- Support across all stages of the product lifecycle
- From pre-Phase 1, proof of concept and approval, to post-approval and lifecycle management
- Global regulatory support
- Experienced regulatory professionals based in North America, Europe and Asia-Pacific with extensive knowledge and established relationships with local regulatory authorities
Our worldwide expertise in regulatory consulting and submissions services are provided from regional centers of excellence in North America, Europe and Asia-Pacific.
