Contact details

Cliodhna McDonough

T: +44 20 7809 2615 M: +44 7711 344 987 Email Cliodhna | Vcard Office: London

Cliodhna McDonough Consultant

Contact details

Cliodhna McDonough

Cliodhna McDonough

T: +44 20 7809 2615 M: +44 7711 344 987 Email Cliodhna | Vcard Office: London

A food and life science regulatory expert uniquely qualified as both a clinical dietitian and regulatory lawyer. Cliodhna is well known and highly regarded for using her broad sense of scientific knowledge and legal expertise to advise across all stages of the food, pharmaceutical, medical device, cosmetic and biotechnology product lifecycle. 
  • Profile
  • Services
  • Sectors

Clients value Cliodhna's practical and commercial approach to complex multijurisdictional regulatory matters and she retains a reputation as a leader in the field for delivering time critical technical programmes essential to success within international regulatory frameworks.

Cliodhna has significant hands on sector experience in assisting clients to navigate and manage all stages of product regulatory compliance; from pre-formulation, manufacture, distribution, marketing, and recall of products to the performance of due diligence and the provision of guidance during regulatory civil and criminal investigations.

Cliodhna has previously worked internally with companies such as L'Oréal and Roche Pharmaceuticals. And has been described by clients as "first class at solving complex technical issues with a pragmatic approach".

In addition to her work as a regulatory lawyer Cliodhna also holds significant professional experience having worked in a medical setting in her capacity as lead hospital clinical dietitian and shares her academic sector knowledge as a visiting food law lecturer and Board member of the Master's of Science EU Regulatory Affairs Degree at the University of College Dublin. Cliodhna was also appointed by the Irish Minister of Health in 2013 to the Government State Board CORU which regulates Health Care Professionals.

"An expert regulatory lawyer who is a powerhouse of sector knowledge, identifies issues quickly and offers swift clear cut advice about what needs to be done"

Managing Director, Medical Nutrition Company 

  • Regulation

Food regulation advice

Cliodhna regularly advises national and multinational companies on product regulatory compliance in areas such as labelling, marketing, and advertising. She has led legal crisis management product recall teams and has significant experience representing companies before state authorities on statutory compliance on food safety issues.

Life science regulation advice

Cliodhna routinely advises pharmaceutical companies, medical devices, universities, venture capital companies, manufacturers, distributors and clinical research organisations on all stages of regulatory compliance during drug development.

Regulation advice on life science development phases

Her experience spans across all development phases such as; clinical trial design and negotiation processes; orphan drug submissions; investigational new drug applications, new drug applications, and biologics licence applications and government contracting related disputes.

US based healthcare technology company

Represented this company during international regulatory compliance proceedings.

Medical device company compliance advice

Routinely advises medical device companies on the compliance matters for the manufacturing and selling of products in EU, US and Asian trade markets.

Cosmetic international regulatory requirements

Significant experience advising international companies on the labelling and marketing of cosmetic products in accordance with international regulatory requirements and assisting in the obtaining of peer reviewed scientific substantiation for product claims.

Good Manufacturing Practices

Advises companies on manufacturing products in accordance with Good Manufacturing Practices (GMP).

International biotechnology companies on regulatory compliance

Significant experience advising biotechnology companies concerning vaccine development; gene therapy technologies; diagnostic medicine; stem cell technologies; drug delivery and design; immunology and virology; and biomedical research and development.

More: Regulation

  • Food and drink
  • Retail and luxury goods
  • Life sciences

Food recall 

Acted as lead legal co-ordinator during a crisis European Food Recall event for a dairy food processing company following the detection of salmonella bacteria in supermarket shelf products. Subsequently acted for the company during investigations with European Regulatory Authorities.

Food Trade Mark Infringement proceedings 

Represented a Medical Nutrition Company during civil litigation proceedings in relation to Trade Mark Infringement.

GDPR and the food and beverage sector 

Advised a global food and beverage company on preparatory steps to ensure regulatory compliance with EU General Data Protection Regulations (GDPR). Advice provided in areas relating to; traceability, customer consent, genome sequencing technologies, food fraud and trans-atlantic data transfers.

More: Food and drink

Asian cosmetics company 

Advised an Asia based Cosmetics Company on regulatory compliance with Good Manufacturing Compliance (GMP), marketing, advertising and labelling prior to EU market entry in addition to registration procedures regarding the Cosmetic Products Notification Portal (CPNP).

Global cosmetics company

Advised a global cosmetics company on cosmetic safety and regulatory compliance issues during litigation proceedings concerning product mislabelling, misleading advertising claims and product safety.

Nutraceutical company 

Advised a global cosmetics company on all regulatory issues regarding the acquisition of a food supplements company including the impact of the acquisition on product reimbursement status.

More: Retail and luxury goods

US based medical device company

Provided regulatory guidance to a US based magnetic resonance imaging (MRI) medical device company on regulatory compliance for clinical evaluations, conformity assessments, CE mark applications, the selling, marketing and advertising of products in the EU market.

International pharmaceutical drug manufacturer

Advised a multinational US based drug manufacturing company on all regulatory aspects on the reorganization of its pharmaceutical business in preparation for London Stock Market introduction including the provision of due diligence for its acquisition of a global skin care division of a competitor company.

Regulatory authority investigation

Represented a European based veterinary drug manufacturing company during preliminary investigations by the European Medicines Agency regarding breaches of internal regulatory compliance procedures and the conditions of its marketing authorisation.

More: Life sciences

Latest news & insights

14 Feb 2019

From Insights

Medical devices regulation countdown

This regulatory topic has become increasingly pertinent, ahead of the countdown to the EU's new medical device and in-vitro diagnostic rules, set to take effect in May..


04 Jun 2018

From Insights

The EU Export Manufacturing Waiver: A boost for the Generic and Biosimilar Medicines Market?

On 28 May the European Commission adopted a legislative proposal for a regulation to amend Regulation (EC) No. 469/2009 on Supplementary Protection Certificates (SPCs)..


02 May 2018

From News

Data exclusivity for medicines: who is protected?

On March 14 2018 the Court of Justice of the European Union delivered judgment on Astellas Pharma v Helm AG and FIMEA in which Astellas challenged a previous decision ..


10 Apr 2018

From Insights

Genomic medicine: regulating clinical pathways

Consultant Cliodhna McDonough shares her views on genomic medicine and regulatory issues which require further analysis with Pharma Times.


© Stephenson Harwood LLP 2016. Any reference to Stephenson Harwood in this document means Stephenson Harwood LLP and/or its affiliated undertakings. Any reference to a partner is used to refer to a member of Stephenson Harwood LLP.