Regulatory approvals, one step ahead.
VRS Healthcare specializes in regulatory affairs consulting, GMP audits, documentation and quality compliance support. We help healthcare and pharma companies navigate complex regulations, achieve approvals faster and maintain world-class manufacturing standards.
- CTD · ACTD · eCTD
- US, EU, ASEAN, GCC, CIS, Africa
- 120+ pharma clients
- M1Administrative & regional information Valid
- M2CTD summaries Valid
- M3Quality (CMC) · AMV, PV, stabilityBuilding
- M4Nonclinical study reports Ready
- M5Clinical · BA/BE reports Ready
End-to-end regulatory services, from dossier to approval.
One team handles the dossier, the data behind it, the submission and the questions that follow. That keeps your filing consistent and your timeline under control.
Regulatory Dossier Filing
Dossier preparation, technical review and compilation in CTD, ACTD and country-specific formats.
Learn moreeCTD Submission & Publishing
Build, view, validate and publish compliant electronic submissions for every major format.
Learn moreDrug Master File (DMF / ASMF)
Open and closed parts of the Drug Master File for API manufacturers.
Learn moreAnalytical Method Validation
Validation reports for dissolution, assay, related substances, residual solvents and micro.
Learn moreBA/BE & Clinical Trial Reports
Bioavailability, bioequivalence and clinical trial documentation.
Learn morePharmacovigilance
PSUR, RMP, PSMF and PV SOPs to keep marketed products compliant.
Learn moreGMP Audits & Quality Compliance
GMP/PIC/S audits, quality documentation and audit readiness.
Learn more+ 7 more services
CDP, labelling and artwork, translation, legalization and apostille, nutra and herbal dossiers, process validation and query response.
View all servicesEvery electronic format, built and validated.
We build, view, validate and publish compliant submissions for the US, EU, Canada and every market where electronic submission applies.
ICH five-module dossier format
ASEAN common technical dossier
Electronic CTD in lifecycle sequences
Working worldwide, from Ahmedabad.
We prepare dossiers for regulated markets and for emerging markets with their own country-specific requirements.
United States
eCTD submissions and DMFs
European Union
eCTD, NeeS, ASMF and IMPD
Canada
eCTD and electronic submissions
ASEAN
ACTD dossiers and VNeeS
CIS
CTD and country-specific dossiers
Africa
CTD dossiers for African markets
GCC
CTD dossiers for Gulf markets
Rest of world
Country-specific and regional formats
A clear path to approval.
Gap analysis
We review your existing data against the target market's requirements and list what's missing.
Documentation
We prepare the dossier, validations, CDP, stability and supporting reports.
Technical review
Every module is checked for consistency, completeness and format.
Publish & submit
We publish, validate and submit in eCTD, CTD, ACTD or the local format.
Queries & lifecycle
We answer authority queries and manage variations, renewals and PV.
Built to widen your chances of approval.
- End-to-end capabilityOur end-to-end regulatory service ensures full compliance with regulatory guidelines and timelines.
- Faster approvalsEfficient, value-added support that helps you obtain regulatory approvals sooner.
- Safety, medical, regulatory and technology togetherSo patients receive the safest, most effective therapies possible.
- Founder-led teamYour project is overseen directly by our founders, from first review to final approval.
GMP documentationQuality documents ready for inspection.Compliance assured98% compliance success rate.
Science-backed dataAMV, CDP, stability and BA/BE.
Approval-ready dossiers300+ successful submissions.Led by people who know the filing.
VRS Healthcare was started in 2020 by an experienced professional team in Ahmedabad. Today we serve pharma companies across regulated and emerging markets.
Meet our founders
Questions, answered.
What does VRS Healthcare do?
VRS Healthcare is a pharmaceutical regulatory affairs consultancy based in Ahmedabad, India. We prepare and file registration dossiers (CTD, ACTD and eCTD), Drug Master Files, analytical and validation documents, pharmacovigilance documents and GMP compliance documentation for pharma companies worldwide.
Which markets do you prepare dossiers for?
We prepare eCTD submissions for regulated markets such as the US, EU and Canada, and CTD, ACTD or country-specific dossiers for ASEAN, CIS, Africa, GCC and other rest-of-world (ROW) markets.
What is the difference between CTD, ACTD and eCTD?
CTD (Common Technical Document) is the ICH format for organising a registration dossier into five modules. ACTD is the ASEAN version of that format. eCTD is the electronic version of CTD, built and validated with publishing software and submitted in lifecycle sequences.
Do you prepare Drug Master Files (DMF / ASMF)?
Yes. We prepare both the open (applicant's) part and the closed (restricted) part of the Drug Master File for API manufacturers, in CTD format, and can publish them electronically.
Can you respond to queries on a dossier that is already submitted?
Yes. We review the authority's query or deficiency letter, coordinate the required data with your team and prepare a complete response for resubmission.
Do you provide pharmacovigilance support?
Yes. We prepare Periodic Safety Update Reports (PSUR), Risk Management Plans (RMP), the Pharmacovigilance System Master File (PSMF) and SOPs for pharmacovigilance surveillance.
How long does dossier preparation take?
It depends on the product, the target market and how much data is already available. We share a clear timeline with every quote after reviewing your documents.
How do I get a quote?
Use the Get Instant Quote button at the top of any page, call +91 90338 25317 or +91 90339 68867, or email ronak_shah@vrshealthcare.in. We reply within one working day.
Planning a submission? Start one step ahead.
Send us the product and the target market. We'll come back with the documents you need, the timeline and a clear quote.