Pharmaceutical and Healthcare

PHARMACEUTICAL AND HEALTHCARE

Pharmaceutical and Healthcare Regulatory and Compliance Support

DWG Next provides comprehensive legal and regulatory counsel to stakeholders across the pharmaceutical and healthcare sectors, addressing the full lifecycle of medicinal products, medical devices, and related technologies. We interpret EU and national regulatory regimes governing product authorisation, clinical trials, and pharmacovigilance, ensuring that client strategies are aligned with applicable legal standards. By formulating tailored transactional frameworks, we enable research, development, and commercialisation activities to proceed within compliant and commercially effective structures. Our work includes addressing market access conditions, public procurement obligations, and pricing mechanisms, particularly within the context of EU health policy. We also guide clients through the complex interplay of intellectual property law, regulatory exclusivity, and competition compliance. Through targeted engagement with regulators, counterparties, and institutional actors, we support clients in resolving disputes and maintaining operational continuity in a heavily scrutinised sector.

We support our clients by:

Advising on pharmaceutical and medical regulatory frameworks, including EMA approvals, clinical trials, and EU drug safety laws.
Structuring and negotiating licensing agreements, R&D collaborations, and technology transfers in life sciences.
Providing legal support in market access strategies, parallel trade issues, and pricing and reimbursement regulations.
Advising on compliance with EU medical device regulations, digital health laws, and telemedicine frameworks.
Managing intellectual property protection, including patent licensing, regulatory exclusivity, and pharmaceutical patent disputes.
Assisting with EU public procurement procedures for pharmaceutical and healthcare products and services.
Drafting and negotiating manufacturing, supply chain, and distribution agreements for pharmaceutical and healthcare entities.
Supporting clients in pharmaceutical M&A transactions, joint ventures, and EU competition law compliance.
Representing clients in regulatory investigations, procurement disputes, and litigation involving pharmaceutical compliance matters.