Regulatory Consulting

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Our Global Regulatory Strategic Consulting and Operational Services Support Your Product Throughout the Development Lifecycle

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 find out how we can assist with global product regulatory activities, throughout the development lifecycle, to accelerate drug approval.

You were wonderful to work with – we appreciate all the good advice you gave and the successful filings made. Hopefully we go into AUS for our development products and I, for one, would think of Syneos Health! All the best.
- Mid-size pharmaceutical company
How We Protect Your Investment

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

  • Agency meetings with EMA, FDA and PMDA for all phases of product development
  • Expedited programs, including Fast Track, Breakthrough therapy, Sakigake Designation and PRIME (PRIority Medicines)
  • Regulatory experts in developing approval strategies in the multifaceted 505(b)(2) drug development environment 
  • 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 Clinical Regulatory Publishing 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
  • Project 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 former agency regulators, industry experts and regulatory writers, many with 25+ years of regulatory and drug/device development experience

- Experts in non-clinical and CMC requirements

  • Support across all stages of the product lifecycle

- From pre-IND, proof of concept, approval, to post-approval and lifecycle

  • Full electronic publishing and submission capabilities

- As well as trusted in-house eCTD-ready core templates and helpful publishing project management

  • Global regulatory support

- Regulatory professionals based in North America, Europe and Asia-Pacific with working 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.