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Overview
A Trusted, Experienced Partner for Regulatory Submissions
The number of clinical documents required by regulatory agencies has increased dramatically with new drug and device safety guidelines. Syntel can help you meet these dynamic regulatory requirements with a suite of submission publishing services for all phases of the pharmaceutical and medical device development process, including consulting, compilation and submission lifecycle management, as well as regulatory IT services.
Our publishing team is made up of doctors, life sciences experts, and technology specialists ready to translate your complex data and results into formatted, regulatory-compliant documents — enabling you to meet strict timelines and secure approvals for your products across multiple global markets.
Offerings
Regulatory Consulting Services
- Regional regulatory consulting
- Strategic planning for fast-tracked products
- Global regulatory intelligence
- Gap analysis
Pre-Approval Services
- Dossier compilation services for FDA, EU, Canada, LATAM, APAC & ROW countries
- Dossier compilation and publishing common technical documents (CTD), eCTD, and non-eCTD electronic submission (NeeS) modules for US, EU, Canada & APAC
- Drug Master Files (DMFs)
Post-Approval Services
- Lifecycle support for variations, renewals and annual reports
- License renewal for Rest of World (ROW) countries
- Regulatory affairs strategic guidance
Submission Services
- End-to end submission publishing services, including document formatting, publishing and quality control
The Syntel Advantage
- Expert team to meet regional regulatory requirements for US Federal Drug Administration (FDA), European Union (EU), Latin American (LATAM), Asia Pacific (APAC) & Rest of World (ROW)
- Consolidated framework for end-to-enddocument management & processing capabilities, including dossier preparation, quality control, submission review and filing
- Intelligent process automation tools to support accelerated processing and operational enhancements
- Scalable, flexible global team to optimize costs and manage peaks and valleys in your submission schedule
- Strategic commitment to invest in solutions, competencies, IP, and infrastructure for regulatory services
- Agile methodology to quickly implement revised plans as regulatory requirements change