Regulatory Affairs Services
Strategic regulatory support across the entire product lifecycle — from planning and CTD/eCTD dossier preparation to submissions, approvals, and post-market surveillance across global markets.
Submissions
Approvals
Markets
Formats
A Clear Path to Market Approval
Regulatory affairs is where drug development succeeds or stalls. Our regulatory team ensures clinical studies and product submissions comply with the frameworks of every target market — minimizing delays, protecting study participants, and giving your product a clear, defensible path to approval.
We provide strategic advice and hands-on execution throughout the lifecycle: planning, gap analysis, dossier compilation, submission, query management, and post-market surveillance — across India, the US, Europe, Brazil, and emerging markets.
End-to-End Regulatory Support
Six service lines that carry a product from regulatory strategy to approval — and keep it compliant after launch.
Dossier Preparation (CTD / eCTD / ACTD)
Module 1–5 compilation, gap analysis, and format adaptation for each target agency — submission-ready the first time.
India: DCGI & CDSCO Submissions
Clinical trial applications, BE study NOCs, new drug approvals, and licensing under the NDCT Rules, 2019.
Global Submissions
US FDA, EMA, ANVISA, and Asian market filings — one core dossier, adapted market by market.
Regulatory Gap Analysis
Systematic review of existing data against target market requirements before you commit to a submission.
PK/PD Integration
Pharmacokinetic and pharmacodynamic evidence woven into the development program to strengthen approval chances.
Lifecycle Management
Variations, renewals, labelling updates, and query responses — support that continues after approval.
CTD vs eCTD vs ACTD — What's the Difference?
Three dossier formats, one goal. Which one your submission needs depends entirely on the market you are filing in — and we prepare all three.
| Aspect | CTD | eCTD | ACTD |
|---|---|---|---|
| Format | Paper / PDF, 5 modules (ICH M4) | Electronic, XML backbone, 5 modules | 4 parts, ASEAN structure |
| Where used | India, ROW markets | US FDA, EMA (mandatory) | ASEAN member countries |
| Lifecycle handling | Manual resubmissions | Sequence-based electronic updates | Per-country variation rules |
| Our support | Full compilation | Compilation & publishing | Format adaptation |
Explore Specific Regulatory Services
Dedicated pages for the submissions we handle most — dossiers, Indian approvals, US generics, and Brazil.
Dossier Preparation
Module 1–5 compilation, gap analysis, and eCTD publishing — submission-ready for every target agency.
Learn MoreDCGI & CDSCO Approvals
Clinical trial applications, BE-NOCs, test licences, and new drug approvals under the NDCT Rules, 2019.
Learn MoreANDA Dossiers
US FDA generic submissions with Module 3 CMC built by people who work with manufacturing daily.
Learn MoreANVISA / Brazil
BE studies at our ANVISA-approved centre plus CTD dossiers and query management for Brazil.
Learn MoreWe Know Module 3 from the Inside
Most regulatory consultants have never stood on a production floor. Celesta Healthcare works with WHO-GMP manufacturing every day — batch records, stability data, process validation, CMC documentation. That manufacturing-side fluency makes our quality dossiers faster to compile and harder to question, and it is something pure consulting firms cannot offer.
From Gap Analysis to Approval
- 01
Regulatory Strategy
Target market mapping, pathway selection, and a submission plan built around your product and timelines.
- 02
Gap Analysis
Existing data reviewed against agency requirements — missing studies and documents identified early.
- 03
Dossier Compilation
Modules 1–5 assembled in CTD, eCTD, or ACTD format with quality, nonclinical, and clinical sections aligned.
- 04
Submission & Follow-Up
Filing with the agency, tracking, and structured responses to queries and deficiency letters.
- 05
Approval & Lifecycle
Post-approval variations, renewals, and surveillance commitments managed for the life of the product.
Regulatory Partners, Not Just Consultants
- Submissions across US, Europe, Asia, India, and Brazil
- End to end: early consultations to post-market surveillance
- Manufacturing-side CMC insight for stronger Module 3 dossiers
- PK/PD and BA/BE data integrated under one roof
- Structured query and deficiency response management
- Transparent, client-centric engagement on every project
Regulatory Affairs — Frequently Asked Questions
1. What is the difference between CTD, eCTD, and ACTD?
2. What are the five modules of a CTD dossier?
3. How long does DCGI approval take?
4. Which regulatory markets do you support?
5. Do you handle post-approval regulatory work?
6. How does PK/PD integration improve regulatory outcomes?
Explore Our Other Clinical Research Services
One research partner from first protocol draft to final approval — every service under one roof.
BA/BE Studies
Bioavailability & bioequivalence studies with LC-MS/MS bioanalysis for regulated markets.
Patient-Based Clinical Trials
Phase I–IV trial management with a pan-India investigator and site network.
Medical Writing
Protocols, CSRs, dossier documents, and publications aligned to ICH, FDA, and EMA.
Planning a Submission?
Tell us the product and the markets — our regulatory team will map the pathway, the gaps, and the timeline before you commit.