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123Our team of professionals will provide you with a variety of services if you have a deficit of time, resources and your capabilities are restricted by budget.

The wide profile of our services to you - our partners - is the solution of problems in the launch of your products on the market and its success in the life cycle of turnover in your interest area.

From consulting to development and implementation of the project by parts or to its full implementation in a particular area or region as a whole. We always have good advice, right decision, and we are ready to propose ways to implement it using our own resources.

Our departments leaders and specialists will work with you to ensure that the objectives agreed in the approved list of services will be implemented and that work is completed in the required time for you and, most importantly, within a certain budget.

Сonsuling
Regulatory activity
Life cycle management
Organization and support of clinical trials II-IV phase
Marketing and post-marketing studies
Pharmacovigilance and safety monitoring
Education and training

helpAdvice on local legislation and regulatory features, the development of regulatory policies with the formation of optimal solutions

You are interested in fate and elimination pathway of your product in one market or group of countries in our region, but you do not know what you need to do - we can help you do this with the help of our experts who have:

  • expert knowledge of legislation and regulations
  • know the problems and answer many questions
  • have a broad network of contacts
  • thoroughly understand the regulatory procedures for a variety of markets
  • know how to optimize logistics solutions

Project-Management-Life-CycleYour product is approved and is on the market.
Necessary to support life cycle - the modifications, changes, quality monitoring andensuring communication with the consumer.

  • Identification of regulatory strategies support modifications of changes
  • Support processes in the authorized bodies
  • Interaction with stakeholders involved in the strategy of removing products on the market - marketing, logistics, commercial office

rdApproval, registration, certification of products for medical use - drugs, biotech products, medical devices, food additives, products for hygiene, veterinary and disinfection, medical equipment, cosmetics.

You made the decision to put your products to particular market. What you need?
Do I need to get approval from the authorized agencies?
You do not have the time and resources for this - we can help you.

Our job is to require the approval of your product for its subsequent commercialization.

You are interested in your products launch on the market of one country or group of countries in our region - we guarantee you entry to one gate to all your area.
You will be working with our Regional and Territorial expert who will provide the correct course of the project and its completion on time and within the agreed strategy and policies of your company.

  • Assessment of eligibility documentation in accordance with local laws
  • Identification of a regulatory strategy based on analysis of your product dossier
  • Support processes in the authorized bodies
  • Project Management
  • Interaction with stakeholders involved in the strategy of access products on the market- marketing, supply chain, commercial office

 8Practical activity that is associated with the identification, assessment, understanding and prevention of adverse negative effects, or any other issue relevant to the drug.

Every company cares about its reputation and in accordance with international standards should provide measures for the collection, analysis and dissemination of information processing on the occurrence of adverse events associated with the use of its products in all territories.

You do not have the time and resources for this - we can help you with providing the following:

  • Collection and processing of spontaneous reports
  • Database management
  • Maintenance of presenting information to the competent authorities
  • Periodic reporting
  • Screening of the literature
  • Training of your staff and medical professionals with regard to safety espects of your product in medical use

We can guarantee strict confidentiality in the handling of information and respect for intellectual property rights

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