Expert Regulatory AFFAIRS and quality Consulting Services
Guiding your medical devices, drug-device combination products and cosmetics to market success in the UK and EU.
About HW Regulatory Solutions
Mission
At HW Regulatory Solutions, my mission is to provide top-quality regulatory affairs and quality management consultancy for medical devices, drug-device combination products and cosmetics to small start-ups through to multi-national companies.
Whatever your requirements, whether looking for a full regulatory package or assistance with discrete projects, I can help you realise your goals effectively, on time and on budget.
Who We are
I am Dr Helen Woolford and I established HW Regulatory Solutions Ltd in 2016. I am a highly experienced consultant specialising in regulatory affairs for medical devices and drug-device combination products. I can also assist with your Quality Management needs for UK and EU medical devices and cosmetics.
Based in the UK, I am committed to helping clients navigate the complexities of regulatory and quality compliance in the EU and UK markets.
I have over 15 years' experience of working in pharmaceutical, medical devices, combination products and cosmetics regulatory affairs consulting supported by practical experience in laboratory-scale drug development. I am a Doctor of Chemistry (2004) and also hold a First Class Hons MChem degree (2000).
Always eager to take on new challenges, I successfully obtained one of the first ever EU MDR Article 117 Drug-Device Combination Product Notified Body Opinions for a multinational pharmaceuticals client in 2020.
I also have a proven track record with navigating medical device CE and UKCA marking as well as maintaining the regulatory compliance of ranges of high-end cosmetic products in the EU and UK, and I am ready to guide you though these processes with ease.
WHAT I OFFER
Medical Devices
- Full regulatory affairs consultancy supporting CE marking under the EU MDR 2017/745 and UKCA marking under the UK MDR 2002
- Regulatory strategy and support from early device development through to product certification and launch
- Liaising with Notified Bodies as your main POC
- Systems and Procedure Packs
- EU MDR Annex XVI Devices without Medical Purpose
- Class III Medical Devices with Ancillary Medicinal Substance
- Labelling and IFU requirements
- Other EU Activities:
- Transitioning of your Technical Documentation for Legacy devices to EU MDR compliance
- EU Person Responsible for Regulatory Compliance
- GSPR checklists
- UDIs
- EUDAMED support
- Navigating complex EU MDR timelines
- Other UK Activities:
- I can be your UK Responsible Person
- Essential Requirements checklists
- Medical device MHRA DORS registration
Drug-Device Combination Products
- Full regulatory support and Technical Documentation preparation for EU MDR Article 117 Notified Body Opinions for integral drug-device combination products
- Proven track record of NB Opinion approvals after just one round of review questions.
- Successfully led and managed one of the first ever Article 117 Notified Body Opinions issued by BSI
- Expertise also includes:
- Advising on CTD and MD Technical Documentation quality content for non-integral combination products (EU)
- Medical Devices with Ancillary Medicinal Substance
Medical and Technical Writing
- Technical Writing:
- Risk Management Files to ISO 14971:2019
- Design History Files
- Manufacturing summaries
- Medical Writing:
- Clinical Evaluation Plans
- Clinical Evaluation Reports
- Literature Reviews and Reports
- Post Market Surveillance:
- Plans and Reports
- PMCF Plans and Reports
Quality Management
- Medical Devices:
- Preparation and review of Quality Management Systems for EU MDR, UK MDR and ISO 13485:2016 compliance
- Drafting procedures
- Managing internal audit processes
- Cosmetics:
- Preparation and review of Quality Management Systems for ISO 22716:2006 Cosmetics - Good Manufacturing Practice
Cosmetics
- UK Responsible Person activities and registration as required by the UK Product Safety and Metrology (Amendment) (EU Exit) Regulations 2009
- UK Cosmetic Product registrations
- Full Product Information File preparation, including Safety Assessments, for compliance with Regulation (EU) 1223/2009, as amended
- Labelling for UK and/or EU compliance
- Formulation compliance and ingredients INCI naming
- Notification of Serious Undesirable Effects in the UK
- Borderlines advice
Contact
HW Regulatory Solutions Ltd
Feel free to contact me anytime!
HW Regulatory Solutions Ltd
17 Yew Tree Park, Congresbury, Bristol BS49 5ER, UK
Office: +44 (0) 1934 834746 Mobile: +44 (0) 7799 595822 Email: helen@hwregulatorysolutions.co.uk
