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Global Regulatory Services (GRS) is a customer focused provider of solutions to the international life science and healthcare industry with a focus on regulatory affairs, compliance and innovation. Our clients range from biotech start-ups to multi-national pharmaceutical companies. We are able to provide a full regulatory affairs service throughout the lifecycle of any medicinal or healthcare product. With an international presence, Global Regulatory Services (GRS) is well placed to help companies enter new territories and markets anywhere in the world.
Why use Global Regulatory Services (GRS)?
- Our unique business model ensures high flexibility and speed of response.
- We have good contacts within key regulatory bodies and health authorities throughout the world.
- Through our well established network of multi-cultural professionals and specialist consultants, we can offer country specific knowledge as well as an international overview.
- We have created teams of professionals dedicated to specialist sectors within the life science and healthcare industry.
- We will help you to plan and understand the registration strategy for today and the long term.
- On your behalf, we maintain an awareness of future regulations and trends keeping you informed of anything which may have, or will have, an impact on your product portfolio.
- By utilising the knowledge and resource of our international network we are able to maximise your chance of success when registering your products.
- early stage development (product and/or company) offering strategic advice
- GxP (Good Practice quality guidelines and regulations, for example: Good Manufacturing Practice)
- generic medicines
- herbal and traditional medicines/natural products/botanicals
- functional foods/nutraceuticals/food supplements
- Advanced Therapy Medicinal Products (ATMPs)/cell therapies/biologics/biosimilars
- medical devices/diagnostics/combination products
- stem cells/regenerative medicine
In addition, through strategic alliances Global Regulatory Services (GRS) can offer
- full pharmacovigilance service (including medical information)
- eCTD templates and publishing
- medical device design and manufacturing support
- a full clinical trial service (adults and paediatrics)
- Patient Information Leaflet (PIL) Readability Testing
- web-based solutions to centrally manage operations
- commercialisation of healthcare, biotech and pharmaceutical technologies/products
Please contact us for further information or to discuss your specific regulatory compliance requirements.