Regulatory Support for Business and Product Market Launch
- Analysis of regulatory requirements and risks when launching new products, services and business models
- Determination of the regulatory status of products
- Development of legal models for entering regulated markets
- Regulatory support for product launch and circulation
- Regulatory due diligence of products and business processes
- Advice on legislative changes and new regulatory requirements
Licensing, Registration and Mandatory Requirements
- Advice on all matters relating to obtaining and amending licences, state registration of products, certification, declaration and conformity assessment
- Technical regulation and EAEU requirements
- Product labelling, packaging and traceability
- Requirements for production, storage, transportation, import and sale of products
Advertising, Marketing and Promotion
- Legal review of advertising and marketing materials
- Support for advertising campaigns and special projects
- Internet advertising labelling
- Promotion of regulated product categories
- Loyalty programmes, promotions, discounts and other sales promotion tools
- Engagement with bloggers, opinion leaders and professional communities
Commercial and Distribution Models
- Development and modification of distribution models
- Supply, distribution, marketing services and other commercial agreements
- Development of trade, pricing, discount and bonus policies
- Interaction with distributors, retail and pharmacy chains
- E‑commerce, marketplaces and distance selling
- Assessment of regulatory and antitrust risks of commercial models
Regulatory Compliance
- Regulatory audit of operations and individual business processes
- Development and adaptation of internal policies and procedures (SOPs)
- Development of regulatory and antitrust compliance systems
- Conducting internal investigations
- Development of corrective measures following inspections and audits
- Employee training
Interaction with Government Authorities
- Preparation of responses to inquiries from government bodies
- Obtaining clarifications, permits and approvals
- Representation of interests in dealings with regulators
- Appeal of decisions, actions and orders of government authorities
Regulatory Support for Transactions and Investments
- Regulatory due diligence in M&A and investment projects
- Analysis of licences, permits and approvals in the context of transactions
- Assessment of regulatory consequences of change of control
- Transfer of licences, registration and permit documentation
- Regulatory support for post‑acquisition integration
- Acting as "global counsel" for international assignments, ensuring adaptation of business models across different jurisdictions
Regulation of Specific Industries and Products
- Pharmaceutical products
- Medical devices and equipment
- Biotechnology
- Dietary supplements and specialised food products
- FMCG and consumer goods
- Digital healthcare and telemedicine
- Artificial intelligence and emerging technologies in regulated industries