Life Sciences
The Life Sciences sector encompasses pharmaceutical development, biotechnology, medical devices, and clinical research. The precision of legal documentation and compliance with regulatory requirements determine the successful market entry of products. Companies must effectively combine scientific validity with compliance obligations, including data protection and intellectual property rights.
We support clients in the planning, regulation, and implementation of innovations. We ensure the creation of internal compliance mechanisms and coordination between regulatory authorities and business teams, allowing scientific progress to translate efficiently into commercial success.
Key challenges in the sector
The sector faces challenges including registration processes, pharmacovigilance, the structuring of clinical trial agreements, collaboration with contract research and manufacturing organizations (CROs and CMOs), and the protection of participants’ personal data under GDPR. Pricing, reimbursement, and market access discussions often determine commercial success. Poorly drafted clinical agreements can lead to the loss of rights to research results or delays in product registration. An insufficiently developed IP strategy in the early stages can hinder future licensing opportunities or fundraising efforts.
Why Nomus
Our experts develop registration strategies, licensing and distribution agreements, and establish compliance mechanisms for pharmacovigilance and personal data protection. We provide expert advice to ensure regulatory compliance and process optimization in order to minimize delays in market entry. We also offer specialized counsel in pricing and reimbursement negotiations, including the preparation of analyses and documentation for communication with public authorities.
For pharmaceutical companies, we provide comprehensive registration strategies—from dossier preparation and guidance in communication with the State Institute for Drug Control (ŠÚKL) to pricing and reimbursement submissions and support during negotiations with regulatory and government bodies. For biotech start-ups, we assist with intellectual property protection and preparation for licensing deals or acquisitions. For medical device manufacturers, we provide support in CE certification and market entry outside the EU. For contract research and testing laboratories (CROs and testing labs), we assist in aligning operations with GxP standards and negotiating agreements with pharmaceutical partners.
We design integrated strategies that account for the entire product life cycle—from intellectual property protection during the research phase, through registration processes and clinical trials, to commercial distribution and post-market surveillance. Our solutions reflect the current requirements of the EMA and the State Institute for Drug Control (ŠÚKL) while anticipating upcoming regulatory changes that may affect your time-to-market. We provide expert advice to facilitate coordination between scientific, regulatory, and commercial teams in order to maximize process efficiency.
Our services for the Life Sciences sector
Intellectual Property
• Patent strategies for pharmaceutical substances and biotechnologies
• Obtaining SPC certificates and data exclusivity protection
• Patent litigation and market entry strategies for generic products
Commercial Law
• In/out-licensing agreements for molecules
• Distribution agreements with pharmaceutical wholesalers
• Clinical Trial Agreements with hospitals and Contract Research Organizations (CROs)
Mergers & Acquisitions (M&A)
• Due diligence for biotechnology and pharmaceutical companies
• Structuring of licensing agreements and milestone payment schemes
• Asset Purchase Agreements for product portfolios
GDPR and Cybersecurity
• Protection of patient data in clinical trials
• Compliance for medical devices with digital components
• Cross-border transfer of health data
Compliance
• Pharmacovigilance systems and adverse event reporting
• GxP compliance audits and implementation of corrective measures
• Anti-corruption programs in the healthcare sector
Competition Law
• Pay-for-delay agreements and generic competition strategies
• Parallel trade and dual pricing systems
• Evergreening strategies and patent settlements
Advertising Law
• Promotion of pharmaceuticals and medical devices
• Health claims and patient communication
• Compliance in interactions with healthcare professionals
Environmental Law
• Management of pharmaceutical waste
• GMO regulation for biotechnologies
• Environmental aspects of manufacturing operations
Litigation and Arbitration
• Patent disputes and litigation concerning Supplementary Protection Certificates (SPCs)
• Product liability and responsibility related to clinical trials
• Disputes arising from distribution and licensing agreements
Schedule an audit of your regulatory documentation – we will identify potential obstacles in the approval process and propose an optimized pathway for registration.
