Service
Regulatory Affairs
Organised, consistent regulatory documentation and intelligence across key authorities.
Overview
Regulatory success rests on consistent, well-organised information. We help teams compile, review and maintain the documentation that supports their regulatory strategy.
We provide support and intelligence; strategy and final regulatory decisions remain with the sponsor and its authorised regulatory leads.
Standards & frameworks we work within
- ICH CTD / eCTD
- CDSCO requirements (India)
- EMA and FDA guidance
- Medical Devices Rules, 2017 (India)
These are frameworks we work within or align to. They do not imply certification, accreditation or endorsement.
What we deliver
- Dossier component compilation and consistency review
- CTD / eCTD structure and content alignment support
- Regulatory gap analysis against guidance
- Regulatory intelligence and guidance tracking
- Labelling and artwork review support
- Responses to agency queries: drafting support
Typical deliverables
- Dossier component packages
- Gap analysis reports
- Regulatory intelligence summaries
- Query response drafts
Engagement models
Project-based
A defined scope, timeline and set of deliverables agreed up front.
Dedicated capacity
Specialists embedded in your workflow on a longer-term, scalable basis.
Advisory & ad hoc
Targeted expert input, reviews or surge support when you need it.
Frequently asked questions
Service descriptions are general and informational. Scope, responsibilities and outputs are defined in a written agreement for each engagement.
Explore other services in the services overview.
Discuss regulatory affairs
Tell us about your programme. We’ll respond with an honest view of how we can help, and where we can’t.