The pharmaceuticals and life sciences sector is one of the most complex and fast-moving industries, shaped by stringent regulatory standards, intensive R&D activities, and ongoing interaction with national and European healthcare authorities.

Companies operating in this market face demanding challenges related to product regulation, market access and reimbursement, innovation protection, business model compliance, and sustainability—within an increasingly competitive and innovation-driven environment.

OUR EXPERIENCE

De Berti Jacchia has a long-standing and well-established track record in advising pharmaceutical companies and life sciences operators, both Italian and international. We support clients through a pragmatic, multidisciplinary approach, combining regulatory, corporate, transactional, contractual, litigation and innovation-related expertise.

We assist clients across the entire product lifecycle—from R&D and clinical development to authorisations and market access, through commercialisation, risk management and disputes, as well as during strategic transformations and extraordinary corporate transactions.

OUR SERVICES

We advise pharmaceutical companies, biotech firms, medical devices and diagnostics manufacturers, CROs, innovative start-ups, investors and healthcare operators.

Our services include, in particular:

• Pharmaceuticals and medical devices regulation (Italian and EU), including authorisation-related and compliance matters
• Clinical trials, contracting with trial sites and CROs, and support to internal functions involved (medical, regulatory, quality)
• Market access, pricing and reimbursement, including interactions with competent authorities
• Relations with AIFA, EMA and other national/EU authorities, and assistance in institutional proceedings and interactions
• Compliance, anti-corruption and organisational models under Legislative Decree 231/2001, including training and control programmes
• Intellectual property and innovation protection, protection and value-enhancement strategies, licensing and technology transfer
• Commercial contracts (supply, distribution, co-marketing/co-promotion, services, quality) and collaboration agreements (R&D, development, manufacturing)
• Distribution and channels (pharmacies, hospitals, wholesalers, e-commerce and OTC channels where applicable), including commercial policies and compliance
• Public procurement and tenders in the healthcare sector, including participation support and dispute management
• Competition law and antitrust compliance in the sector
• Regulatory, civil and administrative litigation, including interim measures and risk management
• Product liability and product safety, including recalls and corrective actions, defence strategy support, and coordination with scientific and technical experts

LIFE SCIENCES TRANSACTIONS (EXTRAORDINARY OPERATIONS)

We assist clients and investors in life sciences transactions, with a focus on sector-specific issues (regulatory, IP, supply chain, quality systems, pharmacovigilance/technovigilance, and product liability exposure).

We advise on, among others:

• M&A and acquisitions of assets/products/portfolios
• Joint ventures and industrial partnerships
• Licensing and technology transfer agreements
• Strategic collaborations (co-development, co-commercialisation, co-promotion)
• Corporate reorganisations and carve-outs, including integrated due diligence and negotiation of transaction documentation