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.
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 60 000$ 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.