Expert Pharma Group Offers Professional Services
in Russia:
Regulatory Services, Preclinical & Clinical Trials, Russian GMP Certification, and Drug Launch

Not only will we register your medicinal products, we will draw up a strategic plan for the promotion of your products on the pharmaceutical market through predictive intelligence, scenario planning, key opinion leaders’ advice and digital intelligence in order to optimize and refine the way you go to market, and successfully stay ahead of the competition.

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Regulatory Services

regulatory support concerning products registration

follow-up of regulatory applications and answers to the concerned Authorities

adaptation of the chemical and pharmaceutical dossier to the new CTD format

preparation and follow-up of Marketing Authorization transfer applications

pharmacovigilance activities

support in transfer of production site

preparation and follow-up of regulatory variation applications

preparation and follow-up of five-yearly renewal application

Receiving registration certificate

Terms: from 2 months

Cost: from 10 000$ US

Preclinical & Clinical Trials

assistance concerning preclinical & clinical trials (bioequivalence & therapeutic equivalence)

follow-up of application to get samples import license

conduct & management of clinical trials (site selection, patients recruitment, monitoring, data management, report preparation)

study design selection and approval

follow-up of application to get PCT & CT permissions

follow up approval at the concerned authorities

preparation and follow up of application at the concerned authorities

Terms:from 2 months

Cost: from 25 000$ US

Russian GMP Certification

support concerning new GMP certificates obtaining

selection & approval of the preferred dates of inspection

follow-up Corrective Action/Preventive Action (CAPA) plans

adaptation of the DMF for the submission

pre-audit of the manufacturing site

Receiving GMP certificate

follow up of applications and answers to the concerned Authorities

official inspection follow-up

Terms:from 2 months

Cost:from 20 000$ US

Drug Launch

advice on access and strategy

portfolio selection & Business case preparation

representative office establishment

market analysis

drug safety and pharmacovigilance activities

turnkey services (drug registration, preclinical & clinical trials, marketing, import, promotion, invoicing and sales)

Terms:from 14 months

Cost:from 150 000$ US

Payment terms: The costs for project is always approved in advance. No hidden costs. Payments in stages. No need to pay the full amount in front. Discounts depend on the total number of projects.

To maximize your capabilities and capacity to launch new drugs with speed, efficiency, and effectiveness, contact Expert Pharma Group. We would be glad to listen to you carefully in order to offer you uniquely customized solutions.