What we offer

End-to-end publishing and submission support across global and local markets, including dossier compilation and publishing in all formats like electronic/eCTD and non-eCTD electronic submission (NeeS) as well as paper submissions of drugs, biologics, and medical devices

Who is it for

Regulatory affairs and submission planning teams

Why it’s important

Get faster approvals on regulatory submissions

Streamline processes around submission templates and formats

Collaborate efficiently with multiple stakeholders

How we deliver

Process

Indegene's publishing team is certified in several software applications used for electronic publishing and comes with extensive experience in planning, preparation, and publishing of premarketing and marketing applications, as well as subsequent life cycle submissions to support initial applications. 


Our team comprises of life sciences experts and technology specialists who convert complex data across multiple global markets into well-formatted, regulatory-compliant documents under stringent timelines. The team possesses a deep understanding of the global regulatory guidelines and requirements and supports dossier compilation and publishing of CTD, eCTD, and NeeS modules, paper to eCTD conversions, legacy document conversions, Drug Master Files (DMFs), product life cycle support for variations, renewals, and annual reports, archival of submission documents and submission sequencing

What makes us different

Multi-shore operating model

Scientific expertise, market knowledge, and technology know-how

Large pool of trained in-house talent

30
Therapy areas
100
Compliance
600
Variations submission per year
NEXT Regulatory Submissions Planning, NEXT HA Query Management