What we do
We don't just prepare documents — we identify weak points before submission, build a strategy, and stay with you through to the result. Our approach is shaped by your situation, not a standard price list.
Where do we start?
Tell us what's happening — we'll find the right format of collaboration.
Early-stage project
The drug exists but the regulatory path isn't defined. You need a strategy: which route to take, what studies are required, and where to start.
Documents ready — need an audit
The dossier is assembled but you're not confident it will survive expert review. You need an outside view — what's weak, what to strengthen before submission.
Received a regulatory query
The regulator raised questions or issued objections. You need help preparing a response — precise, on time, without losing the project's position.
Need clinical trial documents
You need a CT protocol, investigator brochure, clinical dossier section, or other CT documents per EAEU / Ministry of Health requirements.
Need a subcontract expert
You're a КИО, lab, or contractor. You've taken a project with a regulatory component that requires deep expertise. Confidential, without risk to your client relationships.
Need a consultation
You want to understand the situation, assess risks, and get an outside perspective — without any commitment to further work.
Services
Regulatory strategy
Registration route selection, risk assessment, action plan — before documentation begins. Strategy first, documents second.
Registration dossier audit
Clinical section analysis, regulatory risk zone identification, document review. Documents through the regulator's eyes.
Clinical trial documents
CT protocols, investigator brochures, clinical dossier section per EAEU and ICH requirements. Documents that hold up under scrutiny.
Bioequivalence
BE study strategy and documentation, reference drug justification, dissolution profile calculations, biowaiver justification.
Expert support during review
Responses to regulatory queries. Project support throughout interaction with registration bodies.
Subcontract expertise
Confidential expert involvement for КИО teams, labs, and contractors. Closing complex regulatory components.
Ready to discuss your project?
Describe your task — we'll review the situation, identify risks, and propose an approach.
Contact us