Comprehensive Regulatory Support for Global markets
End to end Regulatory Affairs Services covering Regulatory Strategy, Regulatory due Diligence, Scientific Dossier Writing, Marketing Authorization Application Submission to Health Authorities, Deficiency response, Lifecycle management and post-marketing compliance.
- Scientific advice and briefing documentation preparation
- Regulatory strategic guidance for product development, Bioequivalence (BE)/Clinical study
- Strategic advice on exclusivity, IP, and regulatory timelines
- Regulatory pathway assessment
- Country-specific regulatory requirements mapping
- Bridging regulatory strategy between regions
- Regulatory due diligence support (Dossier review, CMC documents, Clinical/BE studies etc)
- Regulatory intelligence
- Orphan drug and pediatric investigation plan (PIP) application
- Support for Compassionate Use and Early Access Programs
- Bridging regulatory strategy between regions
- Global Marketing Authorization Applications (MAA) of Generic, Fixed combination products, Biosimilars, Small molecules for regulated markets (Europe, UK, GCC, Canada, Australia & NZ) and emerging markets (Africa, CIS, SEA, LATAM)
- Scientific dossier writing and CTD/ACTD/eCTD dossier preparation
- Module 1 – Administrative package preparation (as country-specific regulatory requirements)
- Module 2 & 3 – CMC (Chemistry, Manufacturing, and Controls) data review and writing
- Module 4 & 5 – As per requirements and based on literature review
- Country-specific dossier customization
- Responses to Deficiency Questions from Health Authority
- eCTD software support for sequence compilation (validation-ready structure)
- Regulatory Portal Submission (CESP, EMA, MHRA portal etc.)
- eCTD compilation and publishing as per region specific requirements (EU, Swiss Medic, USFDA, Health Canada, GCC etc)
- Technical validation using agency compliant tools
- eCTD Support for Active Substance Master Files
- Nees to eCTD conversion
- eCTD lifecycle management support
- Variations classification assessment and submission as per country-specific guideline requirements
- Renewals or re-registration submission
- Sunset clause monitoring and compliance
- Periodic Safety Update Reports (PSURs)
- MAH transfer application
- DMF/ASMF Preparation and Review (Applicant’s Part and Restricted Part)
- Responses to Deficiency Questions from Health Authority
- End to End solution for CEP and DMF/ASMF registration
Get In Touch
+91 9099123156bd@unicorpharma.com