Our services
Close to Business provides specialized legal services tailored to the needs of companies, particularly in the life sciences sector. We offer expertise in corporat e transactions, compliance, data protection, tax law, commercial contracts, and regulatory matters. With a proactive and flexible approach, we support businesses in navigating complex legal frameworks, ensuring strategic solutions that drive growth and mitigate risks.
CLOSE TO BUSINESS SECONDMENT
Access specialized legal secondees to optimize your team and budget. Close to Business offers an extensive network of high-caliber legal professionals with in-house and law firm experience, available on a full- or part-time basis tailored to your needs.
COUNSEL
Our on-demand model provides immediate access to Senior and Junior Counsel across various practice areas, delivering specialized expertise precisely when needed. This unique approach achieves substantial cost savings while maintaining the highest quality standards.
STRUCTURED TEAM AT YOUR DISPOSAL
Close to Business supports your company with a structured legal team that combines flexibility, innovation, and professionalism. Our integrated solution unites young and experienced lawyers, covering all business areas. A coordinated team, led by senior professionals, manages complex legal initiatives effectively.
TRAINING AND MENTORSHIP
We provide tailored legal training and mentorship for in-house counsel, enhancing expertise in pharmaceutical regulations, compliance, and emerging legal trends. Our programs help legal professionals navigate complex industry challenges with confidence.
COMMERCIAL ACTIVITIES AND AGREEMENTS
We assist clients throughout the entire contract management process from structuring and drafting templates to negotiating and executing commercial agreements. Whether you need support with standard agreements or require guidance on complex License & Distribution Agreements, we have the necessary experience and ad hoc AI tools to help you achieve your goals. We can also assist in updating existing contract management processes and SOPs, optimizing your contract databases, and providing in-house training to the relevant functions.
RISK AND REGULATION
We specialize in providing comprehensive advice on compliance with legal frameworks established by local, EU, and US authorities. Our guidance spans a broad range of areas, including advertising and promotion, market access, pricing and reimbursement, labeling and packaging, drafting of SOPs, Codes of Conduct and Ethics, crime prevention models, and data protection frameworks.
In addition, we actively monitor legislative and regulatory developments affecting the pharmaceutical industry, offering timely updates and analysis to help our clients stay informed and prepared for changes such as the “Reform of the EU pharmaceutical legislation” or the NA Codes of Conduct.
RESEARCH & DEVELOPMENT
Close to Business leverages its expertise to provide specialized advice on a wide range of projects, including the implementation of clinical trials, EAPs and PSPs, market research, and digital & AI tools.
- We facilitate technology transfer and collaborative research initiatives between pharmaceutical companies, academic institutions, and research organizations. Our firm also supports clients in structuring collaborative partnerships, enabling them to capitalize on their innovations and achieve strategic objectives.
COMPLIANCE & PRIVACY LAW
Our team of legal experts provides comprehensive advice on compliance and data protection laws. We specialize in managing complex projects such as whistleblowing and transparency processes, adherence to local Codes of Conduct, records of processing activities, DPIAs, LIAs, data breach procedures, and CRM solutions.
In addition, our team can support you by serving as Data Protection Officer, as well as a member of the Privacy Committee or Supervisory Board.
BUSINESS DEVELOPMENT & STRATEGIC TRANSACTIONS
At our firm, we specialize in providing expert advice on critical strategic transactions. Our services encompass a wide range of deal types, including mergers and acquisitions, distribution agreements, and joint marketing initiatives.
- Our team is highly experienced in the complexities of co-promotion and joint marketing, as well as licensing (in and out), technology transfers, and intellectual property agreements.
TAX AND LITIGATIONS
Close to Business provides specialized assistance in tax matters, offering comprehensive legal services to help pharmaceutical companies navigate complex tax issues and mitigate litigation risks. In the event of tax controversies or disputes with tax authorities, our firm offers aggressive representation to protect our clients’ interests. We have extensive experience in representing pharmaceutical companies during tax audits, appeals, and litigation proceedings at local, national, and international levels. Our attorneys leverage their deep understanding of tax laws and regulations to craft persuasive arguments and negotiate favorable resolutions with tax authorities.
Additionally, our firm specializes in offering expert advice on critical strategic transactions. Our services encompass a wide range of transactions, including mergers and acquisitions, distribution agreements, joint marketing initiatives, co-promotion arrangements, licensing (in and out), technology transfers, and intellectual property agreements. Our team is highly skilled in the complexities of these transactions, providing tailored legal solutions to support the growth and success of our clients in the pharmaceutical sector.
AI expertise
We provide strategic legal support on all aspects of AI, with a focus on compliance with the EU Artificial Intelligence Act (Reg. EU 2024/1689), including system classification, risk management, and obligations for providers, users, and distributors. Our expertise covers data protection under the GDPR when using AI tools, with particular attention to lawful basis, data minimization, transparency, and automated decision-making. We advise on the use of AI in life sciences, especially in clinical trials
