Services

Legal, Regulatory & Ethical Advisory Across the Product Lifecycle

• Strategic advice on legal, ethical and regulatory considerations from early development through post-marketing activities.

• Guidance on regulatory frameworks governing clinical research, product promotion and commercialisation.

• Review and risk assessment of marketing and promotional materials to ensure compliance with applicable laws, industry codes and internal policies.

• Support in developing compliant promotional strategies aligned with regulatory expectations and ethical standards.

Clinical Research & Stakeholder Governance Support

• Advisory services on best practices when engaging with investigators, clinical research organisations (CROs), sponsors, co-collaborators, vendors and service providers.

• Guidance on governance structures, contracting considerations and role clarity across study stakeholders.

• Support in interactions with ethics committees and independent review boards (IRBs), including preparation and review of submission materials.

• Risk mitigation strategies to ensure transparency, accountability and regulatory compliance in clinical research partnerships.

Core Agreements

• Framework & Master Services Agreements (MSAs)

Structuring long-term commercial relationships with clear governance, performance standards, risk allocation and scalability provisions.

• General Services Agreements (GSAs)

Drafting tailored agreements covering scope, deliverables, payment terms, liability and dispute resolution.

• Indemnification Agreements

Allocating risk effectively while protecting commercial and regulatory interests.

• Confidentiality & Non-Disclosure Agreements (NDAs)

Protecting proprietary information, trade secrets and sensitive commercial data.

• Site Contracting Agreements

Supporting clinical research and operational site arrangements with compliant and efficient contract structures.

• Ancillary Services Agreements

Drafting specialised  agreements to support core commercial or clinical operations.

Strategic & Operational Agreements

• Outsourcing & Vendor Agreements

Structuring third-party engagements with clear service levels, KPIs, audit rights and compliance safeguards.

• Data Access & Data In/Out Arrangements

Managing data ownership, transfer rights, regulatory compliance and cross-border considerations.

• Intellectual Property & Licensing Agreements

Protecting, commercialising and structuring IP rights to maximise long-term value.

• Bids & Tenders Support

Assisting with contractual review, risk assessment, compliance positioning and negotiation strategy.

Regulatory Representation

• Acting as the designated Legal Representative under the Clinical Trials Regulation (EU No 536/2014) and applicable UK clinical trial legislation.

• Serving as the official contact point for EU/EEA Member State competent authorities, ethics committees and the UK Medicines and Healthcare products Regulatory Agency (MHRA).

• Ensuring regulatory accountability in accordance with sponsor obligations.

Supporting the establishment of  EU/UK legal entities for non-EU/UK life sciences companies.

EU Clinical Trials Regulation (CTR)

Advisory services on the Regulation (EU) No 536/2014 (EU CTR), which governs the conduct of clinical trials across EU Member States and became fully applicable in January 2022.

GxP (Good “x” Practice)

Advisory services on GxP, which is an umbrella term for quality guidelines and regulations that ensure product quality, patient safety and data integrity.

EU GDPR & UK Data Protection

Advisory services on the General Data Protection Regulation (GDPR) and the UK GDPR, which regulate personal data processing.

US Foreign Corrupt Practices Act & UK Bribery Act

Advisory services on the Foreign Corrupt Practices Act (FCPA) and the UK Bribery Act 2010, which impose strict anti-bribery and corruption obligations.

Sanctions & Trade Laws in Clinical Research

Advisory services on the sanctions regimes (e.g., EU restrictive measures, UK sanctions), which restrict dealings with certain countries, entities and individuals.

EU Data Act & EU Artificial Intelligence Act

Advisory services on the EU Data Act, which aims to regulate the sharing of data generated by connected devices and services. Advisory services on the Artificial Intelligence Act, which establishes a risk-based framework for AI systems.

Development and Implementation of Company Policies, Procedures & Compliance Programmes

Advisory support on effective regulatory compliance and structured governance frameworks.