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Life Sciences

Life sciences businesses and professionals operate under some of the most demanding regulatory scrutiny of any sector. A product safety concern, an adverse event, or an MHRA inspection can escalate quickly, and the consequences reach beyond the company to the directors and senior managers responsible for compliance.

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Harold & McCormack Law is able to advise pharmaceutical, medical device, biotech and healthcare product businesses facing regulatory investigation and enforcement action, including matters involving the Medicines and Healthcare products Regulatory Agency (MHRA). Life sciences organisations often sit under more than one regulator at any one time: MHRA, HSE, local authority environmental health, and in some cases the Care Quality Commission, with a single incident potentially triggering scrutiny from several directions simultaneously. Our regulatory experience and professional discipline work, applies directly to the pressures this sector faces.

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0203 745 2456
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When issues arise

Life sciences investigations are typically triggered by a product safety concern, an adverse event or incident report, an MHRA inspection, a workplace incident in a laboratory or manufacturing setting, a recall decision under review, or an internal compliance or whistleblower concern. Whatever the trigger, early handling shapes everything that follows.

Who we support

We act for both the life sciences businesses and the directors, senior managers and compliance staff who carry personal exposure when things go wrong. Regulatory law in this sector places direct duties on individuals in positions of responsibility, not only on the organisation.

Early advice and investigation management

Early legal advice is critical. Decisions made in the initial stages of an investigation can affect whether enforcement action is taken and how serious it becomes. We advise on engagement with the regulator, evidence gathering and internal investigations, ensuring matters are handled carefully from the outset.

Product safety, recalls and adverse events

Recall decisions and adverse event reporting carry legal as well as clinical and commercial weight. We can advise on the regulatory notification process, support engagement with the MHRA and other relevant bodies, and work alongside your technical and quality teams so that legal exposure is properly considered before decisions are made public.

Interviews, statements and internal investigations

Regulators may seek interviews under caution or request statements from staff. We advise on preparation, attend interviews where appropriate, and run internal investigations discreetly where misconduct, non-compliance or safety concerns are suspected internally.

Prosecution and enforcement risk

Not all investigations lead to prosecution, but the risk must be assessed realistically from the outset. We advise on strategy and represent clients through the enforcement process, including those that lead to prosecution.

Managing reputational impact

A product safety issue or recall in life sciences can attract attention fast. We advise with reputational risk in mind, alongside the legal process, supporting clients to manage all aspects of exposure.

A practical, experienced approach

Life sciences regulation is complex and fast-moving. We bring decades of regulatory and business defence experience to the specific pressures this sector faces, with advice that is clear, direct and focused on protecting your position.

We can support with…

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Corporate Manslaughter

At Harold & McCormack Law, we provide robust legal representation for companies under investigation following a fatality at work. A corporate manslaughter case is amongst the most serious allegations a business can face, with serious legal, financial and reputational risks.

If your organisation is under investigation following a workplace fatality, our experienced solicitors will act fast to protect your legal position and guide you through the process.

What is Corporate Manslaughter

Under the Corporate Manslaughter and Corporate Homicide Act 2007, a company or organisation can be found guilty if a person’s death results from a gross breach of a duty of care due to the way activities were managed or organised.

Investigations are typically triggered by:

  • Fatal accidents in the workplace
  • Construction site or industrial accidents
  • Failings in health and safety policies
  • Deaths in custody or care environments
  • Transport or logistics-related fatalities

Prosecutions are usually brought by the Crown Prosecution Service (CPS) following investigations by the police and Health and Safety Executive (HSE).

Why choose Harold & McCormack Law

  • Specialist Business Defence Lawyers – Decades of experience in corporate crime and regulatory prosecution work
  • Rapid Crisis Response – We act immediately to protect your interests and regain control
  • Prevention-Focused – We advise on remedial steps that may mitigate liability or sentence

Act now – early legal advice is critical

A Corporate Manslaughter case can devastate an organisation. Acting early, securing the right representation and expert handling of the investigation are essential to reducing exposure and securing the best possible outcome.

Who may be at risk

While the charge is against the organisation itself, senior leaders can still face:

  • Individual prosecution for gross negligence manslaughter or related health and safety offences
  • Director disqualification
  • Regulatory enforcement
  • Reputational damage and financial penalties

Our role is to protect both the company and its key people from the outset.

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Corporate Internal Investigations

At Harold & McCormack Law, we provide discreet, strategic legal support to companies conducting internal investigations. Whether you are responding to whistleblower allegations, regulatory scrutiny, or suspected misconduct, we help you manage legal risk, preserve integrity and protect your organisation’s reputation.

Why conduct an internal investigation

Internal investigations are essential when concerns arise about:

  • Fraud, Bribery, or Corruption
  • Employee Misconduct or Harassment
  • Regulatory Non-Compliance
  • Whistleblower Allegations
  • Breach of Internal Policies
  • Financial Irregularities
  • Cybersecurity or Data Breaches

Handled poorly, these issues can escalate into legal action, regulatory penalties or serious reputational harm. Early legal involvement ensures investigations are forensic, evidence-based, impartial, and transparent.

Who we advise

  • Company boards of directors
  • In-house legal and compliance teams
  • HR and risk management departments

A discreet, legally sound approach

Investigations often involve sensitive personnel issues, high-level decision-making, or privileged information. Our solicitors ensure:

  • Legal privilege is preserved as appropriate
  • Confidentiality is strictly maintained
  • Regulatory obligations are met
  • Next steps are clearly advised

Our Internal Investigation Services

We support companies across all sectors with:

  • Independent Investigation Planning and Oversight
  • Interviewing Employees and Witnesses
  • Evidence Review and Digital Forensics
  • Reporting Findings to Boards or Regulators
  • Whistleblower Response and Protection
  • Regulatory Disclosure Advice (e.g. FCA, SFO, ICO)

Whether you are a multinational or a growing SME, we tailor our approach to your risk profile, reporting structures and objectives.

Why choose Harold & McCormack Law

  • Experienced in complex investigations – Including multi-agency cases
  • Regulatory expertise – Skilled in handling SFO, FCA, ICO, and HMRC concerns
  • Protection of your brand and culture – We resolve issues while minimising disruption
  • Proactive risk management – We don’t just uncover problems; we help prevent recurrence
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Environmental Protection

Environmental enforcement in the UK has become increasingly rigorous, with companies and individuals under greater scrutiny from regulatory bodies including the Environment Agency, local authorities, Department for Environment, Food and Rural Affairs (DEFRA) and Natural Resources Wales. Alleged breaches of environmental law can result in significant penalties, criminal prosecution, and reputational damage.

At Harold and McCormack Law, we advise companies, directors, and employees facing investigation or prosecution for environmental offences. Our experience covers a full spectrum of environmental regulations, with a particular focus on pollution, waste disposal, water contamination, and land management.

Responding to enforcement action

When enforcement agencies launch an investigation, prompt legal advice is critical. Investigations may begin with site inspections, interviews or requests for documentation. We help clients respond effectively to these inquiries, protecting their legal position and ensuring compliance with regulatory obligations.

Whether facing a civil sanction, criminal prosecution, or enforcement notice, we provide legal support throughout the regulatory process. We advise on internal investigations, cooperate with regulators when appropriate, and defend clients robustly in the event of enforcement action.

Key areas of expertise

Our work includes defending allegations of unlawful discharges to land or water, breaches of waste handling and storage regulations, pollution from industrial or agricultural activity, as well as failures to comply with environmental permits or planning conditions.

We support clients with responses to enforcement notices, regulatory interviews, court proceedings, and appeals, always ensuring their rights are protected while working to achieve the most favourable possible outcome.

Protecting operations and reputation

Environmental allegations can quickly escalate and attract negative publicity. We work discreetly and strategically to minimise commercial risk, manage stakeholder concerns, and protect business continuity. Our team understands the operational pressures our clients face and works closely with environmental consultants, engineers, and industry experts to provide comprehensive defence strategies.

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Health and Safety

Understanding and complying with health and safety legislation can be challenging and stressful. The sheer volume of complex regulations organisations and individuals must follow means that inadvertent breaches are not uncommon. We know regulatory investigations and enforcement action can be incredibly disruptive to business operations and reputations. Read more >

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Professional Discipline

Our experience in regulatory law enables us to provide a comprehensive service, including advice following a Notification of a Complaint, the subsequent response, and representation during formal interviews, as well as related disciplinary and/or criminal proceedings. Read more >

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Reputation & Crisis Management

Protecting Reputations in a rapidly changing media landscape

In today’s digital age, where news spreads instantly and reputational damage can be long-lasting, effective legal intervention is crucial. At Harold and McCormack Law, we advise individuals and organisations who face reputational threats, whether due to media coverage, online allegations, criminal or regulatory investigations, or other forms of public scrutiny. Read more >

Legal Representation at No Cost to You

If you have insurance, it may cover your legal fees for environmental matters. Our lawyers are well-versed in interpreting policy documents to help you understand the extent of your cover and liaise with your policy provider to support the onboarding process. Contact us today to ensure you have the best legal team supporting you.
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What Our Clients Say

Owner - National
Logistics Company
“We had the best team at the end of the day. Ashleigh and her team all did a great job for us, and we are all so very grateful. The outcome was a testimony to that.”
Westgreen
Construction Ltd
“Ashleigh is an exemplary health and safety legal representative, and I can think of no better legal ally to proactively and reactively support you and your business – the star of her profession.”
Hayley Saunders –
Partner Shoosmiths LLP
“Not only is she a true expert in her field ... She achieves the best outcome for her clients, I wouldn’t hesitate in recommending her.”
MBC Blog
"Ashleigh Harold recognised as 'Best regulatory health and safety lawyer in the UK'"
Farmer, Environment
Agency prosecution
"Ashleigh just a short message to say thanks for the way you presented the case and in fact dealt with the whole case from start to finish. The negotiation skills needed to bring a potentially eye watering fine to £3000 is worthy of mention."
Corporate Client
"You need someone who helps translate the daunting experiences in a manor you comprehend and Ashleigh routinely does this."
Operations Director -
National Steelworks Group
“Could I personally thank you for all of your efforts on our behalf and express our appreciation of your success. There is no doubt that your perception of HSE’s approach to this investigation was accurate. The decision to hold back from the interview was clearly right and limited the opportunity of HSE to secure further evidence...”
Jenna Howard - Director of Little Learners Montessori
"Thanks to Ashleigh our complaint was upheld by Ofsted and we were reinspect a few weeks later and received 'outstanding' in all areas. Ashleigh was absolutely fantastic from start to finish in supporting and guiding us through the process. Thank you so much for all of your help in supporting us and ensuring we received the grade we deserved."
Company Director
"Ashleigh's depth of experience in health and safety law and procecedings is first class - with her case work often referred to as 'the best we have seen' by barristers and QCS alike."
Richard StockwellCompany Director
"When one is confronted with a serious health and safety event you need support, reassurance, knowledge, experience, intuition thoroughness and human understanding - Ashleigh comes with bundles of these attributes."

Frequently Asked Questions

MHRA investigations commonly follow adverse event reports, product safety complaints, inspection findings, or concerns raised through the Yellow Card scheme. Investigations can also arise from whistleblower reports or referrals from other regulators.
Yes. If MHRA has made contact, it is rarely informal. Early advice can make a significant difference to how the investigation unfolds and what obligations apply to you at each stage.
Yes. Individuals in positions of responsibility can face personal criminal or regulatory liability alongside the organisation, particularly where failures in oversight or compliance are identified.
Recall decisions have legal as well as clinical and commercial implications. Legal input before a recall is confirmed ensures regulatory notification requirements and legal exposure are understood.
We coordinate the legal response so that your position is consistent and nothing said to one body creates a problem with another.
As soon as possible. Early legal involvement in life sciences matters before a position is taken publicly or with a regulator and often makes the biggest difference to the outcome.
Cyber Essentials certification is a UK government backed security standard that demonstrates an organisation has implemented the key technical controls needed to protect against the most common cyber threats.

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