Legal Services
Commercial activities
and agreements
We assist clients with the entire contract management process from structuring and drafting templates to negotiating and executing commercial agreements. Whether you need assistance with standard agreements or need to discuss complex License & Distribution Agreement, we have the necessary experience and ad hoc IA tools to help you achieve your goals. We can also help you update the existing contract management processes and SOPs, optimize your contract databases, and provide in-house training to the functions involved.
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Compliance & privacy law
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Our team of legal experts can offer comprehensive advice on matters related to Compliance and data protection laws. We specialize in handling complex projects such as whistleblowing and transparency process, adherence to local Code of Conduct, record of processing activities, DPIA, LIA, Data Breach process, and CRM solutions.
In addition, our team can help you serve as Data Protection Officer, and Privacy Committee & Supervisory Board Member.
Risk and regulation
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We specialize in offering comprehensive advice on complying with the legal frameworks set by the local, EU and US authorities. Our guidance covers a wide range of areas, including advertising and promotion, market access, pricing and reimbursement, labeling and packaging, drafting SOPs, Code of Conduct and Code of Ethics, Model for the prevention of crimes, and data protection framework.
Moreover, we monitor legislative and regulatory developments affecting the pharmaceutical industry and provide timely updates and analysis to help our clients stay informed and prepared for regulatory changes, such as the “Reform of the EU pharmaceutical legislation” or the NA Code of Conducts.
Business development & strategic transactions
At our firm, we specialize in providing expert advice for critical strategic transactions. Our services cover a broad range of transactions, including mergers and acquisitions, distribution agreements, and joint marketing initiatives.
Our team is well-versed in the intricacies of co-promotion and joint marketing, as well as licensing in and out, transfers of technology, and intellectual property agreements.
Research & Development
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Close to Business leverages its expertise to offer specialized advice on a range of projects, including the implementation of clinical trials, EAP & PSP, Market Research, and digital & IA tools.
We facilitate technology transfer and collaborative research initiatives between pharmaceutical companies, academic institutions, and research organizations. Our firm assists clients in structuring collaborative partnerships to help our clients capitalize on their innovations and achieve their strategic objectives.
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Tax and litigations
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Our firm provides specialized assistance in tax matters, offering comprehensive legal services to assist pharmaceutical companies in navigating tax complexities and mitigating litigation risks.
In the event of tax controversies or disputes with tax authorities, our firm provides aggressive representation to protect our client's interests. We have extensive experience representing pharmaceutical companies in tax audits, appeals, and litigation proceedings at the local, national, and international levels. Our attorneys leverage their deep understanding of tax laws and regulations to develop persuasive arguments and negotiate favorable resolutions with tax authorities.