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AX CT specialists provide consulting services for all stages of registration and launch of a medicinal product on the market. We help to organize, conduct and carefully control at all stages of dossier formation, including during preclinical and clinical trials of a medicinal product. We have full control over the drug registration process, saving you time, which allows you to reduce the time to market.
Experienced employees will choose the optimal registration strategy, prepare a review of scientific papers on the results of preclinical studies of drugs, generate a report on the results of bioequivalence studies of the original and generic drugs, prepare documentation and form a registration dossier, eliminate all possible problems when contacting the registration authority.
You can provide only the molecule name, and we will develop the entire strategy for bringing the drug to market: from designing, calculating the sample size, selecting a reference drug, its procurement (in the Russian Federation or import), to writing the final report on the conducted research and submitting it to regulatory authorities.
Fill out the feedback form and we will provide you with a set of documents, which includes: