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Our Government Relations solutions combine legal expertise, policy analysis, and strategic engagement with regulators to minimize risks, accelerate product market entry, and protect business interests.
Pharmaceutical companies, medical device manufacturers, and medical organizations operate under high regulatory pressures.
Medicine and pharmacy
branch
01
provided within the framework of the direction:
GR-support of regulatory processes
Interaction with the Ministry of Health, Roszdravnadzor, FAS, FCS and other agencies
Representation of the company's interests in government agencies
07
03
02
Legal support for athletes and clubs
Pre-trial and judicial settlement of conflicts with regulatory authorities
Optimization of customs procedures for import/export of pharmaceutical products
Protection from unreasonable inspections and administrative pressure
Challenging regulatory decisions (refusals of registration, withdrawal of products, fines)
Interaction with Rospatent and law enforcement agencies
Filing complaints to the Federal Antimonopoly Service about unfair competitors
Reducing the risks of delays at the border through interaction with the Federal Customs Service
GR-support of anti-counterfeit programs
Resolving disputes over the classification of goods and customs duties
Lobbying for changes in legislation
Intellectual property protection and anti-counterfeiting
05
Customs and logistics GR consulting
06
Compliance and pharmacovigilance under GR
Development of internal policies that meet regulatory requirements
Employee training to work in the context of changing legislation
Participation in working groups and expert councils at government agencies
Development and promotion of business-friendly initiatives
Monitoring and analysis of draft laws affecting the industry
Speeding up registration procedures for medicines and medical devices by building a dialogue with regulators
Protection against reputational and legal risks during inspections
services,
Support for digital medical projects
Lobbying for favorable regulatory conditions for digital healthcare
Legal support of medical data processing
Coordination of telemedicine services with the Ministry of Health
08
04
Coordination of research protocols with regulators
Support of inspections and audits by the Ministry of Health
Minimizing bureaucratic barriers during CI
GR-Clinical research support
successfully
implemented
cases
projects
case 1
A young Russian company has developed a breakthrough therapy, but had no experience interacting with regulators.
We have organized a dialogue with relevant medical stakeholders for preliminary approval of requirements.
The drug received a registration certificate in record time, allowing the startup to attract new investments.
We have developed a strategy for accelerated registration using special regulatory procedures for innovative medicines.
situation
result
Our actions
case 2
The international company faced difficulties in adapting its production to the EAEU standards.
We have prepared the client's team for inspection, including trial inspections.
The production was successfully certified, which allowed the launch of production for the entire EAEU region.
We conducted an audit of the company and developed a roadmap for meeting GMP requirements.
situation
result
Our actions
case 3
The domestic manufacturer received an order from Roszdravnadzor to withdraw a series of drugs due to formal inconsistencies.
We have organized negotiations with the regulator to review the decision.
We promptly analyzed the situation and prepared an exhaustive justification for the safety of the drug.
The drug remained on the market, and the company avoided multimillion-dollar losses.
situation
result
Our actions
case 4
A company from Southeast Asia was wasting time and money on customs clearance in Russia.
We have established direct cooperation with the customs authorities.
We have developed a scheme for accelerated customs clearance using preferential treatment.
The delivery time was significantly reduced, and the customer was able to guarantee uninterrupted deliveries.
situation
result
Our actions
case 5
A domestic pharmaceutical company has found signs of preparation for the release of a generic of its drug.
We have initiated claim work with a potential violator.
We conducted a patent audit and registered additional security documents.
The competitor abandoned plans to release a generic drug, while the original drug retained market exclusivity.
situation
result
Our actions
case 6
A foreign startup could not understand the Russian requirements for telemedicine platforms.
We have provided integration with government information systems.
We have adapted the business model to the legislation of the Russian Federation.
The service has received all the necessary permits and has started operating in the Russian market.
situation
result
Our actions
case 7
The manufacturer of a highly specialized drug doubted the prospects of entering the Russian market.
We have prepared a comprehensive justification of the medical value of the product.
The drug has been successfully registered, and patients in Russia have gained access to innovative therapy.
Special regulatory procedures were used for orphan drugs.
situation
result
Our actions
Strategic analysis
Reducing deadlines
Interaction
with key regulators and relevant committees of the State Duma
political and legal trends in medicine and pharmacy
We don't just advise, we build a systematic interaction between business and government so that your company operates in the legal field without unnecessary barriers.
bringing products to market thanks to accelerated approval procedures
with the State through preventive negotiations
Minimizing conflicts
GR-подход
почему
Why is Yang Consult's
GR approach
effective?
Yang Consult —
your reliable
partner
in MEDICINE
activities!
and pharmaceutical
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