Regulatory strategy and documentation for pharma projects
where mistakes cost time, money, and reputation
We help pharmaceutical companies navigate from development to registration — with a clear strategy, solid documentation, and regulatory risks identified in advance.
What we do
Regulatory expertise at every stage — from strategy to registration approval.
Regulatory strategy
Registration route, risk assessment, regulatory plan before documentation starts.
Dossier audit
Clinical section review, gap analysis, expert review before submission to regulator.
Clinical trial documents
CT protocols, investigator brochures, clinical module of the dossier per EAEU and ICH requirements.
Bioequivalence
BE study strategy and documentation, dissolution profile calculations, biowaiver justification.
Expert support
Responses to regulatory queries. Support during interaction with registration bodies.
Subcontract expertise
Confidential expert support for КИО teams, labs, and contractors on complex regulatory tasks.
Dmitry Pavlovich Romodanovsky
19 years of experience in pharmaceutical regulation. Consults on regulatory strategy, clinical trial documentation, bioequivalence studies, and registration dossier audits.
Ready to discuss your project?
Describe your task — we will review the situation, identify risks, and propose an approach.