From the first technical review to post-approval pharmacovigilance, we prepare the documents authorities ask for, in the format each market requires.
Dossiers & submissions
We prepare, technically review and compile registration dossiers for finished pharmaceutical products, and publish eCTD submissions for regulated markets using validated publishing software.
Our publishing team builds, views, validates and publishes compliant submissions for the US, EU, Canada and every market where electronic submission applies.
Nutraceutical, veterinary and herbal products each follow their own registration rules in every country. We prepare dossiers to the requirements of the target market.
When an authority raises a query or deficiency on a submitted dossier, we review it, coordinate the supporting data and draft a complete response to keep approval on track.
We prepare the open (applicant's) part and the closed (restricted) part of Drug Master Files, so API manufacturers can support their customers' filings while protecting confidential process information.
Scientific & technical documentation
We prepare analytical method validation protocols and reports with full raw data, ready for inclusion in Module 3 of the dossier.
Comparative dissolution profiles show that your product performs like the reference product. We prepare CDP reports with the supporting analytical evidence authorities expect.
We compile and review BA/BE and clinical trial documentation, including bioanalytical method validation, study protocols and reports.
We prepare the development and validation documents that support Module 3, with raw data calculations and statistical analysis.
Labelling, safety & post-approval
We prepare and review labelling content and packaging artwork to the regulatory requirements of each target country.
We prepare the pharmacovigilance documents marketing authorisation holders need to monitor product safety and stay compliant after approval.
Many authorities require documents in their national language. We arrange accurate translation of regulatory documents, labels and certificates.
Registration documents often need legalization before an authority will accept them. We manage legalization with embassies and apostille of documents.
Quality & GMP
We help manufacturing sites prepare for and pass GMP inspections, with audits, quality documentation and gap analysis against international standards.
Beyond regulatory
VRS Healthcare is a trusted merchant exporter of pharmaceutical products, medical devices and APIs, combining regulatory expertise with export supply.
We arrange third-party contract manufacturing for partners who need registered, compliant products made to their specification.
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.
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.
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.
Yes. We review the authority's query or deficiency letter, coordinate the required data with your team and prepare a complete response for resubmission.
Send us the product and the target market. We'll come back with the documents you need, the timeline and a clear quote.