Pharma, Life Sciences & Biotech Law

Archon Law advises pharmaceutical, biotechnology, and life-sciences companies on regulatory, compliance, and commercial matters across the entire product lifecycle. We support innovation-driven organisations in navigating European and international regulatory frameworks governing medicinal products, medical technologies, and biotechnological innovation, combining regulatory precision with a pragmatic, risk-aware approach aligned with market and compliance realities.

Pharmaceutical & Life-Sciences Regulatory Advisory

We advise on the regulatory frameworks applicable to medicinal products, biotechnology products, and life-sciences activities at EU and national level.

Services include:

  • Regulatory advisory under EU pharmaceutical legislation

  • Market authorisation strategy and lifecycle planning

  • Regulatory pathways and compliance positioning

  • Interaction with competent authorities and regulators

(Including alignment with guidance and procedures of the European Medicines Agency)

Clinical Trials & Research Governance

We advise sponsors, research organisations, and innovators on compliance with legal and ethical frameworks governing clinical research.

Services include:

  • Clinical trial regulatory compliance

  • Research governance and ethics-committee coordination

  • Informed consent and data-protection considerations

  • Cross-border clinical research coordination

Manufacturing, Distribution & Supply-Chain Compliance

We support life-sciences companies in structuring compliant manufacturing and distribution operations.

Services include:

  • Manufacturing and distribution compliance frameworks

  • Supply-chain governance and contractual structuring

  • Regulatory risk management in distribution networks

  • Product-safety and recall preparedness

Medical AI & Digital Health Regulation

Archon Law advises on the regulatory qualification and governance of AI-driven medical technologies, digital-health solutions, and innovative biotech applications.

Services include:

  • Regulatory qualification of medical AI and digital-health tools

  • Intersection of medical-device law, AI regulation, and data protection

  • Compliance strategy for AI-enabled healthcare products

  • Governance and risk frameworks for innovative health technologies

Pharmacovigilance & Regulatory Risk Management

We advise on ongoing compliance obligations and regulatory risk throughout the lifecycle of medicinal and biotech products.

Services include:

  • Pharmacovigilance and safety-monitoring obligations

  • Regulatory risk assessment and mitigation

  • Compliance incident management

  • Strategic advisory in regulatory investigations

Commercial Agreements in Life Sciences

We support pharmaceutical and biotech companies in structuring and negotiating commercial arrangements aligned with regulatory constraints.

Services include:

  • Licensing and collaboration agreements

  • Research and development agreements

  • Distribution and commercialisation contracts

  • Strategic partnerships and innovation alliances