Taj Pharma's regulatory affairs (RA) team is an active partner in every DEFRATAJ supply relationship - from initial CTD dossier delivery, through registration deficiency responses, into post-approval lifecycle management.
Pre-Registration Support #
- Module 1-5 CTD dossier preparation in target-country format
- Module 1 localisation in EN / FR / PT / ES / AR (other languages on request)
- SmPC, PIL and carton labelling drafting per local requirements
- Legal / administrative documents: CoPP, Free Sale Certificate, GMP certificate, power of attorney, notarisations / apostilles coordination
- Guidance on country-specific format (WHO-PQ aligned; ACTD; country-eCTD; paper)
During Assessment #
- Response to deficiency letters and clarification queries - typical turnaround 10-20 business days
- Supplementary data provision (stability updates, BE data, quality data) as required
- Face-to-face or virtual meetings with regulatory assessors where requested
Post-Approval Lifecycle Management #
| Change Type | Support |
|---|---|
| Type IA / IB variations | Minor manufacturing, specification, analytical method changes |
| Type II variations | Significant quality changes; new pack sizes; indication updates |
| Renewal applications | Supporting data package, safety updates |
| Safety labelling updates | Coordinated with PSUR cycle and global safety signals |
| Packaging changes | Artwork revisions, regulatory notifications |
Pharmacovigilance Interface #
We operate a documented pharmacovigilance system with ICSR handling, Periodic Safety Update Reports (PSUR) and signal management. Distributor PV agreements define reporting responsibilities; adverse events are submitted to local authorities and to our Qualified Person for Pharmacovigilance.
Regulatory Intelligence #
The RA team tracks regulatory updates - WHO guidance, ICH guideline revisions, PIC/S Annex updates, and country-specific changes (e.g. SCAR warnings in SmPC) - and aligns dossier maintenance accordingly.
Team Availability #
Our regulatory team responds to customer queries within 24 business hours. Complex submissions are assigned a named regulatory project manager who tracks the submission through approval and into lifecycle management.