Regulatory, Compliance and Data Protection

Sector regulation, licensing, compliance and data protection

Overview

BIT LAW advises clients on regulatory, compliance, market entry and data protection matters in Serbia, Montenegro and Bosnia and Herzegovina, and across the wider region.

We support companies operating in regulated industries, digital business models and data-driven environments, helping them understand applicable requirements, structure their operations, obtain relevant approvals and implement practical compliance frameworks. Our work includes regulatory analysis, licensing and registration support, internal policies, data protection compliance, digital platform terms, AML/KYC support and regulatory aspects of corporate transactions.

We regularly assist international clients entering or expanding in the region, as well as local companies operating in sectors such as healthcare, pharmaceuticals, laboratories, fintech, factoring, gaming, telecommunications, technology, e-commerce and financial services.

Our approach is practical and business-focused. We help clients identify key regulatory and compliance risks early, translate them into workable action points and implement solutions that support the client’s commercial objectives while meeting local legal requirements.

We also advise clients on data protection and privacy matters, including GDPR-style compliance, local data protection requirements, internal privacy documentation, employee and customer data, cross-border data transfers, data processing arrangements, incident response and communication with the competent data protection authority.

Services

01

Market entry and regulatory analysis

  • analysis of regulatory requirements applicable to new business models and market entry projects;
  • advice on whether a proposed activity requires licences, permits, approvals, registrations or other regulatory steps;
  • legal structuring of local operations in regulated sectors;
  • regulatory feasibility reviews for new products, services and digital platforms;
  • coordination of regulatory workstreams in regional and cross-border projects;
  • practical recommendations for implementing compliant operating models.
02

Licensing, permits and approvals

  • support in obtaining licences, permits, approvals and registrations before competent authorities;
  • preparation and review of application documents and supporting materials;
  • communication with regulators and competent public bodies;
  • advice on ongoing licence maintenance and reporting obligations;
  • support with changes affecting licences, registrations and regulatory status;
  • coordination of regulatory filings in connection with corporate transactions and reorganisations.
03

Regulated industries

  • regulatory advice for healthcare, pharmaceuticals, laboratories and medical services;
  • legal support for fintech, factoring and financial-sector adjacent businesses;
  • regulatory support for gaming and betting operators;
  • advice on telecommunications, technology, e-commerce and digital platform models;
  • support for retail, consumer goods and other regulated commercial activities;
  • sector-specific compliance reviews in connection with acquisitions, investments and operational expansion.
04

Compliance programmes and internal policies

  • compliance checks and regulatory health checks;
  • identification of compliance gaps and preparation of remediation steps;
  • preparation and review of internal policies, procedures and compliance frameworks;
  • AML/KYC compliance support, particularly for fintech, factoring and financial-sector adjacent businesses;
  • advice on consumer protection, website terms, digital services and e-commerce documentation;
  • support in implementing group policies and compliance standards at local level;
  • employee-facing and customer-facing compliance documentation.
05

Data protection and digital compliance

  • data protection compliance reviews and privacy health checks;
  • preparation and review of privacy notices, cookie notices, website terms and internal data protection policies;
  • advice on collection, processing, storage, transfer and sharing of personal data;
  • data processing agreements, controller-processor arrangements and intra-group data transfer structures;
  • GDPR-style compliance support for international groups operating locally;
  • employee data protection, HR privacy documentation and workplace-related data processing;
  • customer, user and platform data processing in digital, fintech, e-commerce and technology-driven business models;
  • advice on cross-border data transfers and coordination with foreign counsel in multi-jurisdictional privacy matters;
  • support in data protection aspects of M&A transactions, due diligence and post-closing integration;
  • advice on personal data breaches, incident response and notification requirements;
  • DPO support and data protection officer services;
  • representation and communication with the competent data protection authority.
06

Regulatory support in transactions

  • regulatory due diligence in M&A transactions, investments and reorganisations;
  • review of licences, permits, registrations and compliance status of target companies;
  • identification of regulatory risks affecting transaction structure, closing conditions, warranties, indemnities and post-closing obligations;
  • advice on regulatory approvals, notifications and filings required for transaction implementation;
  • post-closing regulatory integration and remediation support;
  • coordination with foreign counsel and advisers in multi-jurisdictional transactions.

Sectors

Our Regulatory, Compliance and Data Protection work covers a broad range of regulated and data-driven sectors, including healthcare, pharmaceuticals, laboratories and medical services, fintech, factoring, gaming and betting, telecommunications, technology, e-commerce, digital platforms, financial services, retail and consumer goods, energy, infrastructure and other regulated industries.

We are particularly well placed to support foreign investors and international groups entering or expanding in Serbia, Montenegro and Bosnia and Herzegovina, as well as local companies developing new products, digital services or regulated business models.

Selected matters

A representative slice of recent matters, anonymised. We don't publish client names; references are available privately on request.

01

advising international and local clients on regulatory requirements applicable to market entry, new business models and expansion of operations in Serbia and the wider region;

02

supporting clients in regulated industries with licensing, registration, approval and notification requirements before competent authorities;

03

conducting regulatory and compliance reviews of business operations, internal procedures and commercial documentation, and advising on practical remediation steps;

04

advising clients on regulatory aspects of M&A transactions, including due diligence of licences, permits, approvals, sector-specific compliance requirements and post-closing implementation steps;

05

supporting clients in the healthcare, pharmaceutical, laboratory, fintech, factoring, gaming, telecommunications, technology, e-commerce and financial services sectors on sector-specific regulatory matters;

06

advising clients on AML/KYC, customer onboarding, electronic contracting, e-signing and digital business processes in regulated and technology-driven environments;

07

preparing and reviewing website terms, platform terms, consumer-facing documentation, privacy notices, cookie notices and other digital compliance documentation;

08

advising international groups and local companies on data protection compliance, including personal data processing, employee and customer data, intra-group data sharing and cross-border data transfers;

09

conducting data protection compliance reviews and privacy health checks, identifying documentation gaps and recommending practical steps for alignment with local requirements and GDPR-style standards;

10

preparing and reviewing data processing agreements, internal data protection policies and privacy-related contractual clauses;

11

supporting clients in relation to DPO functions, internal data protection procedures, incident response considerations and communication with the competent data protection authority;

12

coordinating regulatory, compliance and data protection workstreams with foreign counsel and other advisers in cross-border projects and multi-jurisdictional transactions.

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