Case Study: Regulatory Compliance Services
The client is a global medical device and PPE company with over 100 years’ experience distributing products in the medical and sexual wellness categories.
The client needed an outsource regulatory service that could work across their product portfolio to ensure that their medical device Technical Files were compliant.
What we did
Here2Grow developed a project plan with stage reviews, to manage the vast work programme. Our key activities included: technical file reviews, gap analysis and updates working with stakeholders across this global business. We have subsequently, also supported the reporting of serious adverse events and product recalls.
The client has extended the contract and continues to be supported by Here2Grow, we provide monthly progress reports, review critical risks and assist them in developing new in-house SOPs and facilitate regulatory compliance training.
Our other regulatory services cover:
Over the Counter Medicines (OTC); Pharmaceutical Drugs; Medicinal Products; Class I, Class II and Class III Medical Devices and Cosmetic Products.
Other key clients include:
- Delphic HSE